Radar on Specialty Pharmacy

Gaining market access for therapies is key to pharma manufacturers’ success. And it’s not merely access but where on a formulary that access occurs — as well as the formulary tier of competitor products — that’s crucial. To help secure placement, drugmakers enter into contracts with PBMs — and, increasingly, their group purchasing organizations (GPOs) — entities that in turn enter into pharma contracts on behalf of their health plan and employer clients. But these contracts have grown increasingly complex and opaque, and companies should ensure they understand exactly what they’re signing, say industry experts.

These contracts are proprietary, almost always have nondisclosure clauses and vary by manufacturer, PBM and GPO, so many details around them remain unknown. However, sources tell AIS Health that certain standard items should be included. Those include “definitions, financial terms, requirements to qualify for payments, payment timelines, data sharing, confidentiality,” among other aspects, says Katie Asch, Pharm.D., senior director and U.S. consulting pharmacy practice lead at Willis Towers Watson. In addition, states Jenisha Malhotra, senior manager in Risk & Financial Advisory at Deloitte Life Sciences & Health Care, other items that may be addressed are details around the effective dates of the contract; pricing or incentives, including rebates or discounts; eligible products; responsibilities of the contract signees; and eligibility requirements, including eligible facilities.

To serve patients wanting the ability to refill specialty prescriptions online rather than telephoning a pharmacy, AllianceRx Walgreens Prime launched its digital service offering in late 2019. A recent study of people with multiple sclerosis (MS) revealed similar rates of adherence — measured by proportion of days covered — between people managing their prescriptions via online tools vs. telephonic engagement.

In addition to offering self-serve refill requests, the company “wanted to ensure patients using the digital clinical assessment received the same level of quality clinical care required for a specialty patient compared with patients supported by the traditional telephonic process,” says Sabeen Hasni, R.Ph., director of pharmacy quality at AllianceRx Walgreens Prime and a lead researcher of the study. After patients log in and select specialty drugs to refill, they answer operational and clinical questions specific to their condition, including their response to therapy, on-hand supply of medication and side effects. Algorithms can identify those patients who need additional support from pharmacists, and patients can request to speak with a pharmacist at any time. In addition, providers are notified when their patients trigger an intervention protocol, and pharmacists can contact them to discuss next steps in care.

March 11: The FDA granted an additional indication to AstraZeneca and Merck & Co., Inc.’s Lynparza (olaparib) for the treatment of people with germline BRCA-mutated human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with chemotherapy before or after surgery. The agency first approved the tablet on Dec. 19, 2014. Dosing is 300 mg twice daily. Website Drugs.com lists the price of 60 150 mg tablets as more than $7,778.

March 11: The FDA approved another use for Myriad Genetics, Inc.’s BRACAnalysis CDx test as a companion diagnostic to identify people with germline BRCA-mutated HER2-negative, high-risk early-stage breast cancer who may benefit from Lynparza (see above brief). The test detects and interprets germline BRCA1 and BRCA2 variants. The agency initially approved the test on Dec. 19, 2014.

Medicare will cover monoclonal antibodies targeting amyloid for Alzheimer’s disease treatment that receive traditional FDA approval under coverage with evidence development (CED), according to an April 7 final National Coverage Determination (NCD). In addition, for drugs that have not shown a clinical benefit or that receive accelerated approval, Medicare will cover them in FDA- or National Institutes of Health-approved trials. CMS will cover the medication and any related services for Medicare beneficiaries participating in these trials. The move follows a proposed NCD released Jan.11, which received more than 10,000 stakeholder comments.

Horizon Blue Cross Blue Shield of New Jersey filed a lawsuit (No. 1:22-cv-10493) against Regeneron Pharmaceuticals Inc. regarding Eylea (aflibercept), a medication approved for certain retinal diseases, including wet (neovascular) age-related macular degeneration. The suit alleges that Regeneron transferred funds to the Chronic Disease Fund, which offset patient out-of-pocket costs for Eylea but not its competitors. The lawsuit argues that this is an illegal kickback under the Racketeer Influenced and Corrupt Organizations (RICO) Act.

Optum, Inc. recently unveiled Optum Specialty Fusion, a specialty drug management solution that’s focused on streamlining care for people on those products and lowering medication costs. According to the company, which is part of UnitedHealth Group, the approach has the potential to deliver 17% total cost savings in health plans’ medical and pharmacy spend.

Providers are able to request prior authorization for specialty agents via a portal, which then compares treatment options, including their costs, across both the medical and the pharmacy benefit. According to the company, “informed by Optum data and insights, Specialty Fusion provides savings options such as preferred products, dosage management policies, best sites of care and additional cost-control levers such as available discounts and pharmacy networks.” The solution narrows down treatment options to the ones or one that “makes the most clinical and financial sense” and provides approval for that treatment in real time, regardless of the benefit the agent falls under. Optum maintains that this approach lessens “administrative hassle and results in an expected 50% faster access to therapy for patients, while lowering costs.” Specialty Fusion is available for large health plans.