Three Ways to Boost Patient Access to Orphan Drugs—With an Independent Specialty Pharmacy

Today’s guest post comes from Ela Lourido, Vice President of Business Development at Biologics by Mckesson.

Ela discusses the important role independent specialty pharmacies play in educating payers, supporting patients, and ultimately getting potentially life-saving therapies into the hands of patients.

Click here to learn more about Biologics by McKesson's patient access services for biopharmaceutical manufacturing companies.

Read on for Ela’s insights.

Three Ways to Boost Patient Access to Orphan Drugs—With an Independent Specialty Pharmacy
By Ela Lourido, Vice President of Business Development, Biologics by Mckesson

On the heels of achieved regulatory milestones and significant clinical progress, your go-to-market strategy has been strategically built to consider all possible roadmaps for the program. You have hand-selected an ecosystem of vendors that understand your access and distribution challenges and bring forth their respective solutions to address them. The goal is now to deliver your drug to the rare disease patients who have long awaited a viable treatment option.

While there are many attributes that influence network size, the most patient-centric specialty pharmacy model not only enables patient access but also interconnects a limited network of participants deeply aligned to the needs of the rare disease patient and well-versed in fostering positive patient outcomes.

Despite increasing competitive pressures within the specialty pharmacy landscape―such as payer-owned, independent, large and smaller specialty pharmacies―biopharma companies continuously look to leverage the expertise of experienced, independent specialty pharmacies to get ground-breaking rare disease treatments in the hands of patients who need them most.

Here are three key areas where an experienced specialty pharmacy can leverage its internal areas of expertise to offer significant value:

1. Payer Education and Engagement

• Biopharma challenges: Novel therapies for rare, difficult-to-treat therapeutic areas are not immediately well understood by many payers. There is a significant likelihood that education and awareness gaps exist within these reimbursement bodies. So, the responsibility of educating payers about this disease falls on the shoulders of the specialty pharmacy network participants. Additional challenges to be considered include treating orphan diseases, of which there are poorly or essentially undefined clinical precedents.

• Optimal solutions: In the weeks leading up to a drug’s FDA approval, a specialty pharmacy provider can use its industry presence and existing payer relationships to convene roundtable discussions to educate them about the disease. This may include assessing the clinical and economic value of a new market entrant against the cost of the available treatment(s) and standard of care. It can also include explaining how a new treatment may, in fact, translate into health plan savings, easing the initial “sticker shock” that is often associated with a rare disease therapy.
  

2. Patient Access Support

• Biopharma challenges: Before your drug can be dispensed to a patient, a prior authorization will typically be required. The exact list of requirements does vary by payer, but your specialty pharmacy partner(s) should be equipped to contend with the complexities presented in a newly approved therapy. They should research and identify the individual requirements of the health plan and provide the necessary administrative support to combat therapy abandonment.

• Optimal solutions: Conducting proactive payer education and outreach allows all stakeholders to be more responsive in the approval and formulary adoption. Further, a specialty pharmacy partner should provide individualized access support, driving the approval process forward with trained specialists who are knowledgeable about specific payer behaviors, formulary adoption and how to manage prolonged insurance delays.
  
  While payers are still evolving the strategies that drive drug tier selection and prior authorization requirements, the most patient- and provider-friendly QuickStart assistance would allow the specialty pharmacy to connect a patient to their QuickStart/Bridge supply directly. This affords all stakeholders many natural benefits, such as ensuring no delays due to multiple hand-offs; increased simplicity for the manufacturer; and fostering a consistent, exceptional brand experience for patients facing a delay in coverage decision. Once a positive, approved coverage determination has been received, a seamless transition to commercial product can take place.

3. Co-pay Assistance & Financial Support

• Biopharma challenges: It is important to recognize the many direct and indirect costs associated with caring for a patient afflicted with a rare disease. With prices for orphan drugs running up to thousands of dollars a month, a next-generation treatment may not ease existing financial constraints.

• Optimal solutions: To offset the significant out-of-pocket costs associated with chronic, specialty drugs, your selected specialty pharmacy partner should remain current on the availability of foundational assistance. It should also have extensive experience in working closely with nonprofit charitable organizations, advocacy groups within the therapeutic area, and manufacturer-sponsored assistance programs to help patients facing high co-payments, high deductibles and coverage gaps.

When your biopharma company starts planning the commercialization of your new rare disease drug, you need expertise to ensure timely and affordable access for your rare patients. Choose the right specialty pharmacy partner that will make the connections for you. Click here to learn more about Biologics by McKesson's patient access services for biopharmaceutical manufacturing companies.

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