Important Medicaid Information

Medicaid “Unwinding” Is Coming Soon

Do you or a family member currently have health coverage through Medicaid, the Essential Plan or the Children’s Health Insurance Program (CHIP)?

If so, you may soon need to take steps to find out if you can continue your coverage. Soon, states will resume Medicaid and CHIP eligibility reviews. This means some people with Medicaid or CHIP could be disenrolled from those programs. However, they may be eligible to buy a health plan through the Health Insurance Marketplace®, and get help paying for it.

Here are some things you can do to prepare:

-Make sure your address is up to date

-Make sure your state has your current mailing address, phone number, email, or other contact information. This way, they’ll be able to contact you about your Medicaid or CHIP coverage.

-Check your mail

New York State will mail you a letter about your Medicaid or CHIP coverage. This letter will also let you know if you need to complete a renewal form to see if you still qualify for Medicaid or CHIP. If you get a renewal form, fill it out and return it to the state right away. This may help you avoid a gap in your coverage.

What if you don’t qualify for Medicaid or CHIP?

If you or a family member no longer qualify for Medicaid or CHIP, you may be able to buy a health plan through the Health Insurance Marketplace®. Marketplace plans are:

- Affordable. 4 out of 5 enrollees can find plans that cost less than $10 a month.

- Comprehensive. Most plans cover things like prescription drugs, doctor visits, urgent care, hospital visits, and more.

BioMarin - ROCTAVIAN™ (valoctocogene roxaparvovec)

ROCTAVIAN™ (valoctocogene roxaparvovec) is gene therapy for adults with severe hemophilia A. An application for licensing has been before the FDA for some time. Approximately a year and a half ago, the FDA put a pause on review, citing the need for more data. Consequently, BioMarin submitted a three-year data analysis from the ongoing Phase 3 GENEr8-1 study. Earlier this month, BioMarin announced that the FDA has set a new PDUFA Target Action Date of June 30, 2023. PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. The company received Breakthrough Therapy designation for valoctocogene roxaparvovec in 2017.

BioMarin has been aggressively marketing in the EU, especially to health insurance groups in Germany, and expects to sign outcomes-based agreements (OBAs) providing for companion diagnostic testing and reimbursement of ROCTAVIAN with German health insurance groups in the coming weeks. BioMarin's continued progress of the European launch of ROCTAVIAN include plans to hold meetings with authorities in France and the submission of the reimbursement dossier in Italy.

OctaPharma

Octapharma USA, Inc. has submitted a Biologics License Application Supplement to the FDA to expand the approval of wilate®, von Willebrand Factor/Coagulation Factor VIII Complex, to include routine prophylaxis to reduce the frequency of bleeding episodes in children and adults with any type of von Willebrand disease.

Wilate® is currently indicated in children and adults with VWD for on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Additionally, wilate® is indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on-demand treatment and control of bleeding episodes.

Octapharma conducted a study designated WIL-31, a pro- spective, non-controlled, international, multicenter phase 3 trial that investigated the efficacy and safety of wilate® prophylaxis over 12 months in people of age 6 and older with severe VWD of any type except type 2N. The clinical trial's primary purpose was to investigate whether prophylaxis with wilate® lowered the mean total annualized bleeding rate (ABR) compared to the six months of ondemand treatment by more than 50%. Secondary goals were to measure spontaneous ABR and treatment-emergent adverse events.

Researchers reported an 84% reduction in ABR compared with on-demand treatment during a prior study. The median spontaneous ABR decreased by 95%. No serious drugrelated adverse events or thrombotic events occurred during prophylaxis with wilate®.

On February 23, 2023, the U.S. Food and Drug Administration (FDA) approved ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Proteinehtl], previously referred to as efanesoctocog alfa, a first-in -class, high-sustained factor VIII replacement therapy. ALTUVIIIO is indicated for routine prophylaxis and ondemand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A.

ALTUVIIIO is a novel recombinant factor VIII therapy that is designed to extend protection from bleeds with once -weekly prophylactic dosing for adults and children with hemophilia A. ALTUVIIIO has a 3 to 4 fold longer halflife relative to standard and extended half-life factor VIII products. In contrast to other FVIII replacement therapies, it is independent of von Willebrand factor, which imposes a half-life limitation on earlier generation factor VIII therapies.

Hemab Therapeutics

Hemab Therapeutics, a clinical-stage biotechnology company, announced in January the first patient has been dosed in a Phase 1/2 study evaluating HMB-001 for the treatment of the severe bleeding disorder Glanzmann Thrombasthenia. HMB-001 is a bispecific antibody that binds, stabilizes, and recruits endogenous factor VIIa (FVIIa) to the site