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Alabama Letter [RE: Medicaid State Plan Amendment Restricting Utilization of Brand Prescription Drugs]

July 5, 2012

VIA EMAIL

Stephanie Lindsay
Administrative Procedures Officer
Alabama Medicaid Agency
PO BOX 5624
Montgomery, AL 36103-5624
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Dear Ms Lindsay:

The State Patient Access Coalition (SPAC) would like to bring to your attention our concerns with Alabama Medicaid’s recent Medicaid State Plan Amendment restricting utilization of brand prescription drugs. SPAC represents the world’s leading manufacturers and the nation’s leading distributors of blood clotting factor. Blood clotting factors are lifesaving therapies for individuals with bleeding disorders, such as hemophilia and von Willebrand Disease. SPAC was created to address issues of patient access to blood clotting factor and to educate policy-makers about the unique process to manufacture and dispense this vital therapy. SPAC works to ensure that once educated, policy-makers will make sound decisions on policies that affect the purchase, dispensing and administration of blood clotting factor therapies.

We are very concerned with the patient access issues that will arise as a result of Alabama Medicaid’s decision to limit recipients to one brand product per month. Alabama Medicaid has stated they will define brand as one NDC per month. Due to the fact that factor concentrates are dosed based on the patient’s weight, it is not uncommon for an individual with hemophilia to require two different vial dosages of the same brand product to complete a prescription that is closest to the actual prescribed dose from the physician. Each vial will have a different NDC. This means Alabama Medicaid would not even cover a complete prescription for recipients that require blood clotting factor. This is certainly dangerous and contrary to Alabama Medicaid’s mission to “serve eligible, low-income Alabamians by efficiently and effectively financing medical services in order to ensure patient-centered, quality focused healthcare.”

It is also contrary to The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) Recommendation 188 which states that specialty pharmacies shall, “Fill prescriptions within plus or minus 5-10% of prescribed assays, barring extenuating circumstances. This standard shall not be violated by dispensing a number of vials so excessive that it would compromise compliance or so low a dose that it would compromise medical outcome.1” We are concerned that the one-brand limit would compromise medical outcomes.

We understand and appreciate the fiscal difficulties facing Alabama. We don’t believe the policy, which will have the effect of rationing therapy usage for recipients with bleeding disorders, will save the state money when you consider the negative health outcomes of the rationing of therapy. It would not be surprising if inpatient hospitalizations and other adverse events occur as a result of this policy. That certainly would not be beneficial for Medicaid recipients or Alabama’s Medicaid budget.

We understand that the goal of the Alabama one-brand limit is to encourage generic usage whenever possible. We also appreciate the state has already exempted certain products and recipients from the current policy. Due to the uniqueness and personal disease management of patients with bleeding orders, we ask Alabama to exempt blood clotting factors from the one-brand limit.

Blood clotting factors do not have generic equivalents. In fact, the different brands of blood clotting factors are not therapeutically equivalent. The National Hemophilia Foundation’s MASAC strongly states that blood clotting factors are not therapeutically equivalent in their Recommendation 159:

“Clotting factor therapies are neither pharmacologically nor therapeutically equivalent and vary based upon purity, half-life, recovery, method of manufacture, viral removal and inactivation processes, potential immunogenicity, and other attributes. The characteristics of each product and the resultant product choice for an individual patient require a complex decision making process with the ultimate product being agreed upon by the patient and their respective healthcare provider. It is critical that the bleeding disorders community has access to a diverse range of therapies and that prescriptions for specific clotting factor concentrates are respected and reimbursed.”2

The United States Food and Drug Administration (FDA) has approved the various clotting factor therapies [Factor VII, VIII, IX, X and XIII, and von Willebrand Disease] for distinct clinical indications. The therapies are neither clinically nor therapeutically interchangeable. In addition, some therapies are derived from human plasma, while others are made utilizing recombinant DNA technology, created from genetically modified cell lines.

For the reasons stated above, the SPAC would request that Alabama Medicaid consider exempting blood clotting factors from the one-brand limit.

We thank you for your leadership in this effort and hope that the department takes into consideration the importance ofMedicaid recipients having access to their medically appropriate blood clotting factor. I am happy to answer any questions or comments you may have on blood clotting factor therapies.