For Patients and Caregivers

Access and reimbursement resources for your practice

Access and reimbursement resources for your practice

MySMA Support™ offers a range of access and reimbursement resources for your patients and practice after Evrysdi is prescribed, including help with benefits investigations (BIs), resources for prior authorizations (PAs), sample billing and coding information, resources for denials and appeals, information about distribution and referrals to potential financial assistance options.

Quick Links

Help with Coverage (BIs and PAs)
Reimbursement (Billing, Coding and Appeals)
Online Patient Enrollment
Evrysdi Distribution

Coverage

Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources.

Benefits Investigations

MySMA Support™ can conduct a benefits investigation (BI) which can determine:

  • If treatment is covered
  • If treatment is denied
  • If a prior authorization or pre-determination is required*
  • If your patient's insurance plan has a mandated or preferred specialty pharmacy

*If your patient’s request for a prior authorization is not granted, your MySMA Support™ specialist can work with you to determine your next steps.

Get started with enrollment by following the steps below.

Option 1: Submit online

If your practice has a registered account for My Patient Solutions, you can get started by logging into your account.

Don't have an account?

Your patient is required to complete the Patient Consent Form. You can either upload their Patient Consent Form as part of your application or have your patient submit the form via fax, text or e-submit.

  • An online tool to help you enroll patients in MySMA Support™ and manage your service requests at your convenience.

Option 2: Print & fax or text

Step 1: Print the Evrysdi Start Form below and have your patient complete the patient consent section of this form.

Step 2: Print and complete the Prescriber Service Form below.

Step 2: Submit the completed forms via fax or text.

Both sections of the form are required. We must have both sections of the completed Evrysdi Start Form before we can help you.

What to expect next:

  • The request will be processed within five business days upon receipt of both required forms.
  • Your office will be contacted to discuss any next steps.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and healthcare provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.

Case Managers

Evrysdi Case Managers

A Case Manager may assist during your patient's treatment with access and reimbursement.

Learn more about MySMA Support

Evrysdi Starter Program

Patients facing a coverage delay may be eligible for the Evrysdi Starter Program while awaiting a coverage determination. If you would like your patient considered for the Evrysdi Starter Program, you can indicate this when enrolling in MySMA Support with the Evrysdi Start Form.

Eligible patients can receive up to a ~30-day supply of Evrysdi. If the patient continues to experience a coverage delay, the patient may be eligible for one refill (up to a ~30-day supply) of Evrysdi. Once coverage has been determined, the patient no longer qualifies for the Evrysdi Starter Program.

Subject to eligibility requirements and terms and conditions. This program is void where prohibited by law and may not be used in or by residents of restricted states, if applicable.

View full TERMS AND CONDITIONS

Reimbursement

Sample coding information and resources for denials and appeals

Evrysdi Sample Coding

This coding information may assist you as you complete the payer forms for Evrysdi. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding.

Sample Coding: Spinal muscular atrophy (SMA)

Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Appeals

If your patient’s health insurance plan has issued a denial, your MySMA Support™ specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements. 

If a plan issues a denial: 

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your MySMA Support™ specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations are available on the Practice Forms & Documents page.

Appeals cannot be completed or submitted by Genentech on your behalf.

Online Patient Enrollment

My Patient Solutions is an online tool to help you enroll patients in MySMA Support™ and manage your service requests, all through one portal. It allows you the flexibility to work with MySMA Support™ when it’s convenient for you.

With My Patient Solutions, you can:

  • Enroll and re-enroll patients in MySMA Support™ and/or the Genentech Patient Foundation
  • View Genentech Patient Foundation eligibility and coordinate shipment
  • Communicate with your MySMA Support™ specialist
  • Easily identify next steps for service requests
  • View Benefits Investigation reports for all your enrolled patients
  • Follow up on prior authorizations or appeals

 

How to register

Account registration can be completed by one person for the entire practice and for multiple practice locations. For help with registration or if you have questions, call us at 877-GENENTECH (877-436-3683) (9AM-8PM ET, Monday through Friday).

Register for My Patient Solutions

Evrysdi Distribution

MySMA Support™ works with specialty pharmacies (SPs) to help patients receive their prescribed Genentech medicines.

In addition to distributing medicines, a specialty pharmacy may provide the following services:

  • Reimbursement resources
  • Clinical services to help patients throughout their treatment
  • The ability to manage the specialty handling and shipping needs linked with many specialty therapies

You can work with your preferred specialty pharmacy or contact MySMA Support™ to learn which specialty pharmacy the patient’s health insurance plan mandates or prefers.

A specialty pharmacy (SP)* prepares and ships Evrysdi directly to patients each month. Although the SP is not a part of Genentech, it is an important part of the MySMA Support team.

The SP will call the patient or caregiver to welcome them to the program and to schedule delivery times that work best for them. Remind the patient or caregiver to answer calls from the SP to prevent any delays in treatment.

For a full list of in-network specialty pharmacies, please visit the Genentech Access Solutions website or contact MySMA Support™ at 833-387-9734.

*Specialty pharmacies are not part of Genentech and maintain independence in their operations and in their role as a health care provider.

Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item. For any product-specific distribution questions, call MySMA Support™ at 833-387-9734 (9AM-8PM ET, Monday through Friday).

Contact Us

Need more help? Contact MySMA Support™

Call 833-387-9734 (Mon.–Fri., 6AM–5PM PST).

Contact Us

Questions? Contact Evrysdi Co-pay Support

Call (833) 387-9734 (Monday–Friday, 9AM–8PM ET, except major holidays)

Financial support

Financial Support

Find the right financial resources option for your patients.

Explore options
NEXT: Enrollment Forms & Documents

  • We are open from 9AM-8PM ET, Monday through Friday, except for the following holidays:

    • New Year’s Day
    • Martin Luther King, Jr. Day
    • Memorial Day
    • Juneteenth
    • Independence Day
    • Labor Day
    • Thanksgiving Holiday (Thursday and Friday)
    • Christmas Day

Important Safety Information and Indication

Indication

Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

 

Interactions with Substrates of MATE Transporters

  • Based on in vitro data, Evrysdi may increase plasma concentrations of drugs eliminated via MATE1 or MATE2-K, such as metformin
  • Avoid coadministration of Evrysdi with MATE (multidrug and toxin extrusion) substrates. If coadministration cannot be avoided, monitor for drug-related toxicities and consider dosage reduction of the coadministered drug if needed

Pregnancy & Breastfeeding

  • Evrysdi may cause embryofetal harm when administered to a pregnant woman. In animal studies, administration of Evrysdi during pregnancy and/or lactation resulted in adverse effects on development. Advise pregnant women of the potential risk to the fetus
  • Pregnancy testing is recommended prior to initiating Evrysdi. Advise female patients to use contraception during treatment with Evrysdi and for at least 1 month after the last dose
  • There is a pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to Evrysdi during pregnancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-760-1098 or visiting www.evrysdipregnancyregistry.com
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Evrysdi and any potential adverse effects on the breastfed infant

Potential Effects on Male Fertility

  • Counsel male patients that fertility may be compromised by treatment with Evrysdi. Male patients may consider sperm preservation prior to treatment

Most Common Adverse Reactions

  • The most common adverse reactions in later-onset SMA (incidence in at least 10% of patients treated with Evrysdi and more frequent than control) were fever, diarrhea, and rash
  • The most common adverse reactions in infantile-onset SMA were similar to those observed in later-onset SMA patients. Additionally, adverse reactions with an incidence of at least 10% were upper respiratory tract infection (including nasopharyngitis, rhinitis), lower respiratory tract infection (including pneumonia, bronchitis), constipation, vomiting, and cough
  • The safety profile for presymptomatic patients is consistent with the safety profile for symptomatic SMA patients treated with Evrysdi in clinical trials

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

 

 

    • Evrysdi® (risdiplam) Prescribing Information. Genentech, Inc.

      Evrysdi® (risdiplam) Prescribing Information. Genentech, Inc.

    • Data on file. Genentech USA, Inc.

      Data on file. Genentech USA, Inc.

    • NIH US National Library of Medicine. Spinal muscular atrophy. https://ghr.nlm.nih.gov/condition/spinal-muscular-atrophy. Accessed June 7, 2021.

      NIH US National Library of Medicine. Spinal muscular atrophy. https://ghr.nlm.nih.gov/condition/spinal-muscular-atrophy. Accessed June 7, 2021.

    • Farrar MA, Park SB, Vucic S, et al. Emerging therapies and challenges in spinal muscular atrophy. Ann Neurol. 2017;81(3):355-368.

      Farrar MA, Park SB, Vucic S, et al. Emerging therapies and challenges in spinal muscular atrophy. Ann Neurol. 2017;81(3):355-368.

    • Sumner CJ, Crawford TO. Two breakthrough gene-targeted treatments for spinal muscular atrophy: challenges remain. J Clin Invest. 2018;128(8):3219​-3227.

      Sumner CJ, Crawford TO. Two breakthrough gene-targeted treatments for spinal muscular atrophy: challenges remain. J Clin Invest. 2018;128(8):3219​-3227.

    • Cure SMA. Voice of the patient report: spinal muscular atrophy (SMA). https://curesma.wpengine.com/wp-content/uploads/2018/01/SMA-VoP-for-publication-1-22-2018.pdf. Published January 10, 2018. Accessed June 7, 2021.

      Cure SMA. Voice of the patient report: spinal muscular atrophy (SMA). https://curesma.wpengine.com/wp-content/uploads/2018/01/SMA-VoP-for-publication-1-22-2018.pdf. Published January 10, 2018. Accessed June 7, 2021.

    • Prior TW, Leach ME, Finanger E. Spinal Muscular Atrophy. In: Adam MP, Ardinger HH, Pagon RA, et al., eds. GeneReviews®. Seattle (WA): University of Washington, Seattle; February 24, 2000.

      Prior TW, Leach ME, Finanger E. Spinal Muscular Atrophy. In: Adam MP, Ardinger HH, Pagon RA, et al., eds. GeneReviews®. Seattle (WA): University of Washington, Seattle; February 24, 2000.

    • Hamilton G, Gillingwater TH. Spinal muscular atrophy: going beyond the motor neuron. Trends Mol Med. 2013;19(1):40-50.

      Hamilton G, Gillingwater TH. Spinal muscular atrophy: going beyond the motor neuron. Trends Mol Med. 2013;19(1):40-50.

    • Baranello G, Bloespflug-Tanguy O, Darras BT, et al. FIREFISH Part 1: 24-month safety and exploratory outcomes of risdiplam (RG7916) in infants with Type 1 spinal muscular atrophy (SMA). Supplemental presentation at: 2020 Virtual World Muscle Society; September 28-October 2, 2020; Virtual.

      Baranello G, Bloespflug-Tanguy O, Darras BT, et al. FIREFISH Part 1: 24-month safety and exploratory outcomes of risdiplam (RG7916) in infants with Type 1 spinal muscular atrophy (SMA). Supplemental presentation at: 2020 Virtual World Muscle Society; September 28-October 2, 2020; Virtual.

    • Day JW, Annoussamy M, Baranello G, et al. SUNFISH Part 1: 24-month safety and exploratory outcomes of risdiplam (RG7916) treatment in patients with Type 2 or 3 spinal muscular atrophy (SMA). Presentation at: 2020 Virtual SMA Conference; June 8-12, 2020; Virtual.

      Day JW, Annoussamy M, Baranello G, et al. SUNFISH Part 1: 24-month safety and exploratory outcomes of risdiplam (RG7916) treatment in patients with Type 2 or 3 spinal muscular atrophy (SMA). Presentation at: 2020 Virtual SMA Conference; June 8-12, 2020; Virtual.

    • Darras BT, Boespflug-Tanguy O, Day JW, et al, on behalf of the FIREFISH Working Group. FIREFISH parts 1 and 2: 24-month safety and efficacy of risdiplam in infants with type 1 SMA. Poster presented at: Muscular Dystrophy Association Clinical and Scientifi c Conference; March 13-16, 2022; Nashville, TN.

      Darras BT, Boespflug-Tanguy O, Day JW, et al, on behalf of the FIREFISH Working Group. FIREFISH parts 1 and 2: 24-month safety and efficacy of risdiplam in infants with type 1 SMA. Poster presented at: Muscular Dystrophy Association Clinical and Scientifi c Conference; March 13-16, 2022; Nashville, TN.

    • Cances C, Vlodavets D, Comi GP, et al; ANCHOVY Working Group. Natural history of type 1 spinal muscular atrophy: a retrospective, global, multicenter study. Orphanet J Rare Dis. 2022;17(1):300.

      Cances C, Vlodavets D, Comi GP, et al; ANCHOVY Working Group. Natural history of type 1 spinal muscular atrophy: a retrospective, global, multicenter study. Orphanet J Rare Dis. 2022;17(1):300.

    • Poirier A, Weetall M, Heinig K, et al. Risdiplam distributes and increases SMN protein in both the central nervous system and peripheral organs. Pharmacol Res Perspect. 2018;6(6):1-12.

      Poirier A, Weetall M, Heinig K, et al. Risdiplam distributes and increases SMN protein in both the central nervous system and peripheral organs. Pharmacol Res Perspect. 2018;6(6):1-12.

    • Baranello G, Darras BT, Day JW, et al. Risdiplam in Type 1 spinal muscular atrophy. N Engl J Med. 2021;384:915-923. doi: 10.1056/NEJMoa2009965.

      Baranello G, Darras BT, Day JW, et al. Risdiplam in Type 1 spinal muscular atrophy. N Engl J Med. 2021;384:915-923. doi: 10.1056/NEJMoa2009965.

    • Darras BT, Baranello G, Boespflug-Tanguy O, et al. FIREFISH Part 1: 24-month safety and exploratory outcomes of risdiplam in infants with Type 1 spinal muscular atrophy (SMA). Presentation at: 2021 Virtual MDA Conference; March 15-18, 2021; Virtual.

      Darras BT, Baranello G, Boespflug-Tanguy O, et al. FIREFISH Part 1: 24-month safety and exploratory outcomes of risdiplam in infants with Type 1 spinal muscular atrophy (SMA). Presentation at: 2021 Virtual MDA Conference; March 15-18, 2021; Virtual.

    • Servais L, Oskoui M, Day JW, et al, on behalf of the SUNFISH Study Group. SUNFISH parts 1 and 2: 4-year efficacy and safety of risdiplam in types 2 and 3 spinal muscular atrophy (SMA). Presented at: American Academy of Neurology; April 22-27, 2023; Boston, MA.

      Servais L, Oskoui M, Day JW, et al, on behalf of the SUNFISH Study Group. SUNFISH parts 1 and 2: 4-year efficacy and safety of risdiplam in types 2 and 3 spinal muscular atrophy (SMA). Presented at: American Academy of Neurology; April 22-27, 2023; Boston, MA.

    • Mercuri E, Barisic N, Boespflug-Tanguy O, et al. SUNFISH Part 2: efficacy and safety of risdiplam (RG7916) in patients with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). Presentation at: 2020 Virtual American Academy of Neurology (AAN) Conference; April 25-May 1, 2020; Virtual.

      Mercuri E, Barisic N, Boespflug-Tanguy O, et al. SUNFISH Part 2: efficacy and safety of risdiplam (RG7916) in patients with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). Presentation at: 2020 Virtual American Academy of Neurology (AAN) Conference; April 25-May 1, 2020; Virtual.

    • Annoussamy M, Seferian AM, Daron A, et al; NatHis-SMA study group. Natural history of Type 2 and 3 spinal muscular atrophy: 2-year NatHis-SMA study. Ann Clin Transl Neurol. 2021;8(2):359-373.doi:10.1002/acn3.51281.

      Annoussamy M, Seferian AM, Daron A, et al; NatHis-SMA study group. Natural history of Type 2 and 3 spinal muscular atrophy: 2-year NatHis-SMA study. Ann Clin Transl Neurol. 2021;8(2):359-373.doi:10.1002/acn3.51281.

    • Bérard C, Payan C, Hodgkinson I, et al., and the MFM Collaborative Study Group. A motor function measure scale for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005;15:463-470.

      Bérard C, Payan C, Hodgkinson I, et al., and the MFM Collaborative Study Group. A motor function measure scale for neuromuscular diseases. Construction and validation study. Neuromuscul Disord. 2005;15:463-470.

    • Trundell D, Le Scouiller S, Le Goff L, et al. Assessment of the validity and reliability of the 32-item Motor Function Measure in individuals with Type 2 or non-ambulant Type 3 spinal muscular atrophy. PLoS One. 2020;15(9):e0238786. doi: 10.1371/journal. pone.0238786.

      Trundell D, Le Scouiller S, Le Goff L, et al. Assessment of the validity and reliability of the 32-item Motor Function Measure in individuals with Type 2 or non-ambulant Type 3 spinal muscular atrophy. PLoS One. 2020;15(9):e0238786. doi: 10.1371/journal. pone.0238786.

    • Vuillerot C, Payan C, Iwaz J, et al. Responsiveness of the motor function measure in patients with spinal muscular atrophy. Arch Phys Med Rehabil. 2013;94(8):1555-1561.

      Vuillerot C, Payan C, Iwaz J, et al. Responsiveness of the motor function measure in patients with spinal muscular atrophy. Arch Phys Med Rehabil. 2013;94(8):1555-1561.

    • Mazzone ES, Mayhew A, Montes J, et al. Revised upper limb module for spinal muscular atrophy: development of a new module. Muscle Nerve. 2017;55:869-874.

      Mazzone ES, Mayhew A, Montes J, et al. Revised upper limb module for spinal muscular atrophy: development of a new module. Muscle Nerve. 2017;55:869-874.

    • Pera MC, Coratti G, Mazzone ES, et al. Revised upper limb module for spinal muscular atrophy: 12 month changes. Muscle Nerve. 2019;59:426-430.

      Pera MC, Coratti G, Mazzone ES, et al. Revised upper limb module for spinal muscular atrophy: 12 month changes. Muscle Nerve. 2019;59:426-430.

    • Mazzella A, Curry M, Belter L, et al. “I have SMA, SMA doesn't have me”: a qualitative snapshot into the challenges, successes, and quality of life of adolescents and young adults with SMA. Orphanet J Rare Dis. 2021;16(1):96.

      Mazzella A, Curry M, Belter L, et al. “I have SMA, SMA doesn't have me”: a qualitative snapshot into the challenges, successes, and quality of life of adolescents and young adults with SMA. Orphanet J Rare Dis. 2021;16(1):96.

    • Wan HWY, Carey KA, D’Silva A, et al. “Getting ready for the adult world”: how adults with spinal muscular atrophy perceive and experience healthcare, transition and well-being. Orphanet J Rare Dis. 2019;14(1):74.

      Wan HWY, Carey KA, D’Silva A, et al. “Getting ready for the adult world”: how adults with spinal muscular atrophy perceive and experience healthcare, transition and well-being. Orphanet J Rare Dis. 2019;14(1):74.

    • Albers CA, Grieve AJ. Test review: Bayley, N. (2006). Bayley Scales of Infant and Toddler Development–Third Edition. San Antonio, TX: Harcourt Assessment. J Psychoeduc Assess. 2007;25(2):180-198.

      Albers CA, Grieve AJ. Test review: Bayley, N. (2006). Bayley Scales of Infant and Toddler Development–Third Edition. San Antonio, TX: Harcourt Assessment. J Psychoeduc Assess. 2007;25(2):180-198.

    • Darras BT, Boespflug-Tanguy O, Day JW, et al, on behalf of the FIREFISH Working Group. FIREFISH Parts 1 and 2: 24-month safety and efficacy of risdiplam in infants with Type 1 SMA. Poster presented at: Muscular Dystrophy Association Clinical and Scientific Conference; March 13-16, 2022; Nashville, TN.

      Darras BT, Boespflug-Tanguy O, Day JW, et al, on behalf of the FIREFISH Working Group. FIREFISH Parts 1 and 2: 24-month safety and efficacy of risdiplam in infants with Type 1 SMA. Poster presented at: Muscular Dystrophy Association Clinical and Scientific Conference; March 13-16, 2022; Nashville, TN.

    • Finkel RS, Farrar MA, Vlodavets D, et al, on behalf of the RAINBOWFISH Study Group. RAINBOWFISH: Preliminary efficacy and safety data in risdiplam-treated infants with presymptomatic SMA. Poster presented at: Muscular Dystrophy Association Clinical and Scientific Conference; March 13-16, 2022; Nashville, TN.

      Finkel RS, Farrar MA, Vlodavets D, et al, on behalf of the RAINBOWFISH Study Group. RAINBOWFISH: Preliminary efficacy and safety data in risdiplam-treated infants with presymptomatic SMA. Poster presented at: Muscular Dystrophy Association Clinical and Scientific Conference; March 13-16, 2022; Nashville, TN.

    • Baranello G, Day JW, Deconinck N, et al, on behalf of the SUNFISH Working Group. SUNFISH: efficacy and safety of risdiplam in Types 2 and 3 SMA. Poster presented at: European Paediatric Neurology Society; April 28 - May 2, 2022; Glasgow, UK.

      Baranello G, Day JW, Deconinck N, et al, on behalf of the SUNFISH Working Group. SUNFISH: efficacy and safety of risdiplam in Types 2 and 3 SMA. Poster presented at: European Paediatric Neurology Society; April 28 - May 2, 2022; Glasgow, UK.

    • Chiriboga CA, Bruno C, Duong T, et al. JEWELFISH: 24-month safety, pharmacodynamic and exploratory efficacy data in non-treatment-naïve patients with SMA receiving treatment with risdiplam. Presentation at: 2022 Virtual World Muscle Society (WMS) Conference; October 11-15, 2022; Halifax, Canada.

      Chiriboga CA, Bruno C, Duong T, et al. JEWELFISH: 24-month safety, pharmacodynamic and exploratory efficacy data in non-treatment-naïve patients with SMA receiving treatment with risdiplam. Presentation at: 2022 Virtual World Muscle Society (WMS) Conference; October 11-15, 2022; Halifax, Canada.

    • Kletzl H, Cleary Y, Grimsey P, Gerber M, Scalco RS. Risdiplam: pharmacokinetic, pharmacodynamic, safety and efficacy exposure response analyses. Poster presented at: Cure SMA 2022 Research and Clinical Care Meeting; June 15-17, 2022; Anaheim, CA.

      Kletzl H, Cleary Y, Grimsey P, Gerber M, Scalco RS. Risdiplam: pharmacokinetic, pharmacodynamic, safety and efficacy exposure response analyses. Poster presented at: Cure SMA 2022 Research and Clinical Care Meeting; June 15-17, 2022; Anaheim, CA.

    • Iannaccone ST, To TM, Dickendesher T, Shapouri S, Pineda ED. A retrospective analysis of adherence and persistence among risdiplam-treated patients with spinal muscular atrophy (SMA). Poster presented at: Muscular Dystrophy Association Clinical and Scientific Conference; March 19-22, 2023; Dallas, TX.

      Iannaccone ST, To TM, Dickendesher T, Shapouri S, Pineda ED. A retrospective analysis of adherence and persistence among risdiplam-treated patients with spinal muscular atrophy (SMA). Poster presented at: Muscular Dystrophy Association Clinical and Scientific Conference; March 19-22, 2023; Dallas, TX.