Focus on Specialty Pharmacy

On Tuesday’s update we noted that Joanne Stubbings, B.S. Pharm., MHCA, announced the creation of the Section of Specialty Pharmacy Practitioners. It’s the first new section created in twelve years. Three thousand AHSP members have already registered, representing a cross section of health system pharmacy. The section’s mission is to advance the cause of health system-based specialty pharmacy practice. Three advisory groups have been created: workforce development, business development, and outcomes and values. 

The Board of Pharmacy Specialties notes that “With specialty-trained pharmacists as part of the collaborative care team, enhanced patient satisfaction has been documented with fewer complications in drug treatment; improved laboratory monitoring; reductions in unnecessary medications; and shorter hospital stays resulting in lower treatment costs.  BPS currently provides board certification in Ambulatory Care, Nuclear Pharmacy, Nutrition Support, Oncology, Pharmacotherapy and Psychiatric Pharmacy.  Certification exams for Critical Care and Pediatric Pharmacy are in development.”

APhA defines Specialty pharmacy as focusing on the provision of high cost, high touch medication therapy for patients with complex disease states. Medications in specialty pharmacy range from oral to cutting edge injectable and biologic products. The disease states treated range from cancer, multiple sclerosis and rheumatoid arthritis to rare genetic conditions.  
The Pharmaceutical Pipeline Tracker can provide valuable clinical formulary decision support for Specialty Pharmacists. Investigational drugs in the above-mentioned disease states are covered comprehensively in our knowledgebase. The Pharmaceutical Pipeline Tracker helps to manage the disruptive impact of the launch of new specialty drugs on formulary management and provides actionable clinical decision support.

For example, there are twenty-one different therapeutic categories and one hundred forty-seven investigational cancer drugs in our knowledgebase. The FDA approved Loxo Oncology/Bayer’s larotrectinib (Vitrakvi) on 11/26/18 for the treatment of adult and pediatric locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion regardless of site. Larotrectinib is dosed as a 100 mg capsule twice a day in adults and 100 mg/Meter-Squared orally twice daily in children. WAC for a 30-day supply of the drug will be $32,800 for adult dose capsules and start at $11,000 per month for a pediatric liquid. This is the second biomarker guided therapy after the approval of pembrolizumab last May for the treatment of microsatellite instability-high cancer in any location. Bayer and Loxo provide a value-based contract for larotrectinib that will refund payers and patients for patients who do not see a clinical benefit within the first three months of treatment. The companies will also offer patient assistance and reimbursement programs to lower patient costs. Loxo estimates there are 1,500 and 5,000 late-stage cancer patients in the U.S. and a similar number in Europe with the mutation.

There are twelve investigational drugs targeting Multiple Sclerosis in our knowledgebase. For example, Novartis’ siponimod has a PDUFA Date of March 31, 2019. The drug has no FDA Priority Designations. There are links to six studies in the knowledgebase to fully functional MedLine monographs. At this point in time, none of the other eleven MS drugs under development have PDUFA dates.

We’ve aggregated a large knowledgebase of investigational specialty drugs. One may choose to access information about these drugs by using one of three methodologies: by Therapeutic Category, by PDUFA Date, or by Indication. Click on each search type to link to more information about each methodology.