This year has proved eventful for specialty pharmacy. Our industry is booming, with new players entering the market and specialty pharmacy spending far outpacing traditional drug sales. Some 43 new drugs – including a totally new class of medications called PCSK9 inhibitors – received FDA approval this year, according to a report from the pharmaceutical industry news provider FirstWord Pharma.
The industry also has seen changes in accreditation standards, distribution and pricing programs, and approaches toward data collection.
Looking back at 2015, Therigy’s Russel Allinson, CEO and Chief Clinical Officer, and Lily Duong, Vice President of Clinical Programs, identified major specialty pharmacy events and trends that marked 2015 and that will continue to have a significant impact in 2016.
- Approval of PCSK9 inhibitors.
Last summer, the FDA approved two highly anticipated drugs that were part of a new class of medications known as PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitors.
The new drugs, Praluent® (alirocumab, manufactured by Regeneron and approved in July) and Repatha™ (evolocumab, made by Amgen® and approved in late August) target high LDL levels for patients whose cholesterol is not sufficiently lowered by diet and lifestyle changes and first-line statin use, or those who cannot take statins due to side effects.
Both have the opportunity to become blockbusters, Allinson and Duong said, and sales could reach $1 billion. Concerns remain, however, about prescription and distribution channels, pricing and other factors. One interesting trend to watch is whether these products are further restricted to the specialty pharmacy channel by payors or if they will expand in the retail/independent channel.
The TherigySTM Hyperlipidemia Module was developed and made available last fall to give specialty pharmacies enhanced options for managing clinical care for patients prescribed PCSK9 as well as those taking range of cholesterol treatments, including, statins, HoFH (Homozygous FH) medications, and other lipid-lowering drugs.
- More health systems entering the specialty market.
Traditional drug spending has been basically flat, but the specialty pharmacy market is growing at a rate of 20 percent per year. With that kind of increase and market forecast, starting a specialty pharmacy operation can be a way for health systems to expand their pharmacy services and gain additional drug revenue, where available.
“Given the infrastructure and capital requirements of starting a specialty pharmacy,” Allinson said, “health systems are uniquely qualified to develop care centers and clinical processes around their existing client populations and distribution channels.”
With its consulting and data resources, Therigy has guided a number of health systems to develop their own specialty pharmacies. Therigy also offers an Accreditation Acceleration program to augment the health system specialty pharmacy accreditation process by providing project management and/or technical leadership.
- 340B growth.
The 340B Drug Discount Program is a federal program requiring drug manufacturers to provide outpatient drugs to eligible health care organizations and other covered entities at reduced prices with the intent of stretching resources and providing coverage and more comprehensive services to as many eligible patients as possible.
Most of the 340B recipient organizations have been hospitals that treat large numbers of low-income patients. The program allows them to buy drugs for significantly less than market price – but the number of eligible entities has exploded and critics charge that some hospitals are using the funds they save on medications to pad their profits.
“This has drug companies lobbying for changes in the program,” he said, “and payors looking to for ways to share in the margin savings afforded by this legislation.”
- URAC 3.0 Accreditation.
Back in the late spring, the accrediting agency URAC released Specialty Pharmacy Standards 3.0. As Therigy’s Pam DeVaul, Vice President of Quality, noted at the time, the new requirements represented not a small update, but rather major changes to significant portions of the accrediting process. Accreditation is now required for participation in most payor contracts as well as many manufacturer limited distribution programs.
For specialty pharmacies, one of the most significant changes in URAC 3.0 was the requirement to have a Care Management Plan in place. Specialty pharmacies generally do not provide direct care to patients, DeVaul said, and did not have information systems to support the new required documentation.
All of the new standards have been incorporated into TherigySTM, the market leader in clinical management software for specialty pharmacies, giving client pharmacies pre-configured care plans that meet URAC standards. Also included is advanced data reporting to meet URAC and other stakeholder reporting requirements and easy integration with pharmacy dispensing systems.
- Limited drug distribution on the rise.
Specialty pharmacies are finding themselves in competition with each other to qualify for limited distribution channels. What’s happening, Allinson said, is that the requirements for inclusion in limited distribution programs/contracts are tighter than ever.
Drug manufacturers also are increasingly launching specialty drugs in limited distribution as well as evaluating open distribution models that have been in place for years. Factors that drug makers consider when choosing distribution partners, Allinson said, include accreditation, performance measures, dispensing capabilities, reporting capabilities, and payor market share.