A new era in specialty pharmacy

Specialty medication approvals continue to outpace those of traditional medications each year, and with the approval of the first biosimilar this spring, the specialty market is only gaining momentum.

Administration of these complex drugs often requires special processes, high-touch care, and a thorough understanding of disease states and potential side effects. In response, specialty pharmacists are providing needed services at every level.

See also: Pathways to specialty pharmacy

Hepatitis C

Each year more advanced specialty drugs enter the market to treat complex diseases such as hepatitis C, rheumatic diseases, and cancer. And not only are the numbers of specialty drugs increasing; they are also starting to draw more competition from new alternative and biosimilar formulations.

Aimee TharaldsonSofosbuvir (Sovaldi; Gilead Sciences) now has to share the market with other effective therapies for the treatment of patients with hepatitis C. However, when it was first introduced in late 2013, sofosbuvir made waves across the healthcare community for both its high cost and its potential impact on patients with hepatitis C. Clinical trials have shown that more than 95% of patients with hepatitis C were able to achieve a sustained virologic response after taking the drug, but with an average wholesale price of about $1,000 a pill, its use called for a costly investment.

In December 2014, FDA approved ombitasvir/paritaprevir/ritonavir with dasabuvir (Viekira Pak; Abbvie Inc.), giving rise to Sovaldi’s first competition, and pharmacy benefit managers (PBMs) are taking note.

"Express Scripts made a landmark decision to exclusively cover Viekira Pak, which significantly reduced the cost of care and now makes this curative therapy available to all patients, not just the sickest," said Aimee Tharaldson, PharmD, senior clinical consultant for Express Scripts.

See also: Specialty drugs and the role of managed care pharmacy

Cancer and RA

This year has also marked the approval of the first biosimilar, filgrastim-sndz (Zarxio; Sandoz), formulated to compete with Neupogen (Amgen) to reduce rates of infection in certain cancer patients during chemotherapy. The drug can be used to treat all nonmyeloid cancer types in patients taking myelosuppressive chemotherapy, as well as in acute myeloid leukemia patients.

Infliximab (Inflectra; Hospira), a new biosimilar intended to compete against Janssen’s rheumatology drug Remicade, could also be approved as early as this year. The approval and launch of the drug are currently delayed by pending litigation; if approved, Inflectra would be the first monoclonal antibody in biosimilar form in the United States. Its potential uses include treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and ankylosing spondylitis.

Many of the specialty drugs moving through the pipeline are intended to treat cancer. According to Tharaldson, approximately 35% of all specialty drugs now in development are for cancer. About half of them will be oral formulations.

Some of the most notable trends are occurring in the treatment of lung cancer, said Tharaldson, and particularly for non-small-cell lung cancer (NSCLC). Nivolumab (Opdivo; Bristol-Myers Squibb), a programmed death receptor-1 (PD-1) inhibitor, was granted expanded approval in March to treat NSCLC. Another PD-1 inhibitor, pembrolizumab (Keytruda; Merck Oncology)‎, is expected to receive approval for this indication this fall. Two oral, next-generation epidermal growth factor receptor (EGFR) inhibitors for NSCLC, AZD-9291 (Astra Zeneca) and rociletinib (Clovis Oncology), are also expected to gain approval by mid-2016.

One significant trend in the cancer pipeline, according to 2014 report from The IMS Institute for Healthcare Informatics, is the development of targeted therapies and agents that work with molecular targets and biomarkers. For this reason, a significant number of drugs under investigation for the treatment of colorectal, breast, and ovarian cancer would target different mutations (KRAS, BRAF, and ALK) as well as human epidermal growth factor receptor 2 (HER2).

Skyrocketing costs

Stephen SchondelmeyerThe surge in specialty drugs is associated with increasing costs to the healthcare system.

Stephen W. Schondelmeyer, PharmD, PhD, a pharmacist and economist at the University of Minnesota's College of Pharmacy and director of the PRIME Institute, said that while the average one-month supply of generic medications costs about $35 to $40 and the average cost of a branded drug is around $400-$500 a month, the average price for a one-month supply of a specialty medication soars to approximately $3,500 to $4,000 per prescription.

"Each one is a tenfold jump over the other," said Schondelmeyer, who also serves as an editorial advisor for Drug Topics.

The drug responsible for the highest prescription drug expenditures in 2014 was sofosbuvir. According to a recent analysis led by Glen T. Schumock and published in the American Journal of Health-System Pharmacy, sofosbuvir was responsible for $6.6 billion in expenditures in 2014 alone. It accounted for most hepatitis C antiviral expenditures - 78.2%.

Another drug in the infectious disease category, pegfilgrastim (Neulasta; Amgen), was noted as the object of one of last year’s highest total expenditures, almost $2.9 billion. The man-made protein used to prevent neutropenia earned the 10th spot on the list of top drugs in 2014, as indicated by most dollars spent.

Four drugs used to treat rheumatoid arthritis also made the list. According to the analysis, adalimumab (Humira; AbbVie) ranked fourth at $5.2 billion, etanercept (Enbrel; Amgen) ranked seventh at approximately $4.0 billion, infliximab (Remicade) ranked ninth at $3.4 billion, and rituximab (Rituxan; Biogen Idec/Genentech) ranked 13th at almost $2.6 billion. Infliximab also earned the top spot in a list of drugs receiving the highest expenditures made by nonfederal hospitals in 2014.

Rituximab can also be used to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia; however, it wasn't the only oncology drug associated with high expenditures last year. The report also assessed top antineoplastic drug expenditures in 2014 and reported that bevacizumab (Avastin; Genentech) - used to treat colorectal cancer, cervical cancer, lung cancer, kidney cancer, platinum-resistant ovarian cancer, and recurrent glioblastoma - came in second highest among antineoplastic drugs, drawing expenditures of almost $1.7 billion in 2014.

Trastuzumab (Herceptin; Genentech) earned third place in monies spent on antineoplastic drugs, at approximately $1.3 billion. The cancer drug, which acts by interfering with the growth and spread of cancer cells, has been used to treat HER2-positive breast cancer, metastatic stomach cancer, and gastroesophageal junction cancer.

Cost implications for patients

Patients are not immune to the significant costs associated with specialty medications, many of which are responsible for more cost-sharing and higher co-payments for patients seeking to obtain these drugs.

According to Schondelmeyer, patients taking specialty medications aren't the only ones feeling the impact of rising costs. Often health plans spread the cost of these pricey medications across their covered population through increased premiums.

"We also have to remember that even though the majority of people may have insurance of some type, insurance doesn't create new money to pay for things. It is just a way of managing and spreading the risk across the population, but it doesn't finance the cost of new drugs," he said.

For example, one client he works with increased its premiums by 10% across the board just to cover costs associated with hepatitis C and multiple sclerosis drugs, even though only about 0.15% of the population received the medications.

Medical vs. pharmacy benefit

Lisa HolleSpecialty medications can be covered one of two ways, through either the medical benefit or the pharmacy benefit, depending on the location in which the drug is administered. Drugs administered in a physician's office, such as infliximab, fall under the medical benefit, while only self-administered drugs fall under the pharmacy benefit.

Lisa Holle, PharmD, BCOP, assistant clinical professor, Department of Pharmacy Practice, University of Connecticut School of Pharmacy, said that as more oral cancer therapies enter the market, more patients may find themselves receiving at least a portion of their therapy at home. This creates potential barriers for patients who don't have a good prescription drug plan or have no prescription drug coverage at all.

"The cost to them is much higher than if they get an IV chemotherapy, regardless of whether there's an IV drug available or not," she said.

According the IMS Institute report from 2014, the average monthly cost of branded oncology drugs was about $10,000 in 2013.

Patient access

Mary DorholtExperts agreed that the high price tags associated with specialty medications have created access-related problems for patients.

Mary Dorholt, PharmD, senior director and clinical practice lead for Accredo, the specialty pharmacy for Express Scripts, said that Express Scripts recently conducted an analysis to determine just how high patient costs could go before they start having an impact on patient adherence. They found that the tipping point tends to be at $250.

"When patients have to pay out-of-pocket more than that for a prescription, [$250] tends to be the point where they really start not taking their medication as they are supposed to," she said.

Patient asistance

To help alleviate some of the financial burden for patients, pharmacists can turn to patient assistance programs and manufacturer coupons to help patients find financial relief.

In a recent Prime Therapeutics study of the impact of manufacturer coupons and patient-assistance programs, it was found that one specialty pharmacy was able to apply a coupon or patient assistance program to four out of 10 specialty drug prescriptions in the first six months of 2013, which resulted in a $10.6 million reduction in the drug cost to members. The study concluded that specialty pharmacies should consider including coupon and patient-assistance program optimization as part of their services.

But Holle cautioned that these programs aren't a solution for all patients. "It sounds great, and there are a lot of programs available through pharma companies, but the biggest barrier to that is that Medicare patients aren't allowed to participate in the pharma-company-sponsored programs," she said.

Biosimilars

Biosimilars could provide another alternative to reducing costs, but according to some experts, it's too early to tell whether the government will create the market conditions necessary to make biosimilars a competitive option.

"I do think the concept of biosimilars - if implemented in similar ways to the way the Hatch-Waxman law was implemented - could reduce costs, but so far the FDA has made choices in implementation that don't follow the pattern of the Hatch-Waxman Act," Schondelmeyer said.

For instance, Zarxio wasn't granted interchangeable status with Neupogen. Schondelmeyer also pointed out the fact that the drug company's name is allowed as part of the nonproprietary name given to a product, saying that most state laws are not currently written to allow the substitution of a biosimilar.

However, the drug could pave the way for significant cost savings, Tharaldson said. "Although the manufacturer hasn’t announced U.S. pricing yet, we anticipate that Zarxio will save the U.S. healthcare system $5.7 billion over the next decade," she said.

The role of the specialty pharmacist

Vickie AndrosWhen it comes to use of specialty medications, specialty pharmacists can be a critical part of the medical team and have been shown to improve adherence and patient outcomes. These pharmacists often help patients gain access to their medications by securing prior authorizations or helping patients connect with patient-assistance programs.

Curant Health's “C The Cure” program was created to help patients with hepatitis C better manage their disease and achieve better health outcomes.

Vickie Andros, PharmD, Curant's director of clinical services, said that specialty pharmacists in the program work as an extension of the medical team.

"We do help with [patient] access to appropriate therapy, and the way that we do that is [by offering] prior-authorization assistance. We will work with the healthcare team to obtain whatever clinical information is needed to complete the prior-authorization form, submit the prior-authorization form, and then follow up with insurance as well, to check on status," she said.

This assistance not only relieves some of the burden for other medical team members, Andros said, it also improves medication adherence by ensuring that patients have access to the drugs they need and have a point of contact for help with any problems they may encounter.

Medication therapy management

Amy HamptonSpecialty pharmacists affiliated with the program also provide medication therapy management services with regular follow-up for patients as they work through their drug regimens.

"On average we're seeing hepatitis C patients on the newer therapeutic agents ... for about 12 weeks. According to our protocol, a patient who is on HCV therapy for 12 weeks will be contacted a minimum of five times as part of our MTM program, by a clinical pharmacist," said Amy Hampton, hepatitis program director and business development director for Curant Health.

Using a high-touch care model is often necessary because of the complexity of care many of these patients require. At Accredo, many pharmacists spend most of their time working with patients in one disease category, becoming true experts about the unique needs of that patient group.

"Many of these drugs have dosing regimens that are complicated and may require injection. [Injections] are very difficult to manage. Patients may have side effects that are difficult to manage, more so than seen in the traditional space," Dorholt said.

Adherence-based outcomes

Specialty pharmacists have said that adherence is often key to achieving better patient outcomes, and many studies have found that patients have better outcomes when working with a specialty pharmacy rather than other dispensing channels.

For instance, one study, conducted by Jay Visaria, PhD, MPH, and colleagues and published in the American Journal of Managed Care, found that patients with chronic myeloid leukemia who started a new course of imatinib therapy (Gleevec; Novartis) and were part of a specialty pharmacy group were 1.46 times more likely to attain optimum drug adherence compared with patients in the other pharmacy group.

Another study, led by Jane F. Barlow, MD, MPH, MBA, and published in 2012 in the American Journal of Managed Care, found that specialty pharmacy management not only increased adherence to rheumatoid arthritis medication therapy; it also reduced medical resource use and medical costs.

Accredo also reported seeing positive outcomes for its rheumatoid arthritis patients. "We see medical costs go down when patients are actually adherent to their drugs. They don't go to the ER as often. And sometimes patients need a lot of help to stay adherent," Dorholt said.

Jill Sederstrom is a freelance writer based in Kansas City.

Educational opportunities for specialty pharmacy

Specialty medications are used to treat complex conditions and often require special storage and handling, administration, or ongoing monitoring. Due to the complex nature of these drugs, pharmacists who handle them need to be well educated and informed, in order to offer patients the clinical expertise necessary.

To obtain greater knowledge about specialty medications, some pharmacists are turning to certification programs.

The Specialty Pharmacy Certification Board, which became an accredited certification program last fall, offers pharmacists an opportunity to become certified specialty pharmacists. To achieve the certification, licensed pharmacists must have 3,000 hours of specialty pharmacy practice in three years and 30 hours of specialty pharmacy education in two years, and they must pass the certification exam, said Gary M. Cohen, BS Pharm, RPh, CSP, executive director and founder of the organization.

The Board of Pharmacy Specialties (BPS) also offers a certification program in oncology pharmacy, which enables pharmacists to become board-certified oncology pharmacists.

BPS Executive Director William M. Ellis, RPh, MS, said that pharmacists can follow one of three different pathways to be eligible to sit for the boards: a two-year pathway, a three-year pathway, or a four-year pathway.

"There are more than 1,300 individuals now who hold board certification in oncology. It's the third-largest BPS specialty," he said.

The American Society of Health-System Pharmacists and the American College of Clinical Pharmacy also offer courses to help pharmacists prepare for taking the BPS Oncology Pharmacy Specialty Certification exam.

Cohen said that pharmacists who are looking for other educational opportunities should consider the Specialty Pharma Education Center, which offers nearly 300 hours of continuing pharmacy education for pharmacists seeking to learn more about specialty drugs.

- Jill Sederstrom