Biologics are Effective but Costly in Managed Care

San Antonio—The increasing role of biologics in treating diseases has benefited patients, but it has also led to rising costs. When assessing medications to prescribe, healthcare professionals need to evaluate their safety and effectiveness as well as their price and quality.

At the AMCP meeting, speakers discussed biologics for oncology, multiple sclerosis (MS), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and other conditions during a satellite symposium titled Optimal Use of Biologics in Delivering Value-Based Care: Challenges for Managed Care Pharmacy. Genentech and Biogen Idec supported the session with educational grants.

Douglas S. Burgoyne, PharmD, president at VRx Pharmacy Services, defined a specialty pharmaceutical as requiring a difficult or unusual process of delivery to the patient or patient management before or after administration. Of the pipeline drugs, approximately 50% are biologics, which are considered as part of the specialty umbrella. The costs of specialty drugs range from $500 to $2500 per month.

There has also been an increase in orphan drugs, which the FDA defines as products that treat rare diseases affecting fewer than 200,000 people. Dr. Burgoyne noted that there are nearly 7000 rare diseases, many of which are serious and life-threatening. Between 2001 and 2011, the number of drugs in development to treat rare diseases increased from 64 to 140.

The most common therapeutic area among products in the pipeline is cancer (3070 drugs), including chemotherapy and biologics, according to Dr. Burgoyne. Whereas chemotherapy attacks cancer cells directly, biologics help the immune system fight the cancer.

Costs and Protocols for Biologics

Dr. Burgoyne cited a survey from The Zitter Group in 2011 in which payers believed they could cut 22.7% of cancer treatment costs without negatively impacting health outcomes. Oncologists and practice managers responded that they could reduce costs by 18% and 15.9%, respectively, without negatively impacting health outcomes.

To help decide where to cut costs and determine preferred protocols, Dr. Burgoyne suggested that guidelines such as those from the National Comprehensive Cancer Network (NCCN) be stratified by costs and survival rates. He added that each protocol should be aligned with a certain amount of reimbursement and that payers should encourage using preferred protocols by implementing a tiered oncology benefit program.

When confronted with increasing cancer costs, most payers reduce reimbursement to oncologists, increase the use and restrictions of prior authorizations, mandate the use of specialty pharmacists, or implement other site-of-care rules. Dr. Burgoyne suggested another effective option is using clinical pathways that provide an evidence-based approach and specify the interventions to use and in what sequence to use them. For the past few years, payers have used pathways for breast, colorectal, and lung cancers and have been based on collaborations between physicians and payers.

Biologics for MS are also expensive, according to Dr. Burgoyne. Of the FDA-approved therapies, the cheapest is teriflunomide (average wholesale price of $49,846 per year) and the most expensive is glatiramer acetate ($66,304 per year).

Partnering with Patients and Healthcare Providers

John Fox, MD, senior medical director and vice president of medical affairs at Priority Health, recommended that an option to deal with the high costs and issues related to biologics is for providers to form partnerships based on the Institute for Healthcare Improvement’s Triple Aim of improving the patient experience of care, improving the health of populations, and reducing the per capita cost of care. They can also follow the NCCN guidelines and utilize biomarkers that can assess if a person is likely to develop cancer, identify what type of cancer he or she has, predict what drug would be best to use, and determine the possibility of the cancer returning.

Dr. Fox noted that targeted therapies can be effective and mentioned patients with BRAF V600E mutated malignant melanoma have benefited from the introduction of vemurafenib. The FDA approved vemurafenib in August 2011 with an accompanying companion diagnostic test to help determine if the patient has the BRAF V600E mutation. Dr. Fox said companion diagnostics help cut costs, but the savings and response rate decrease as the disease progresses.

Considering patients’ viewpoints and preferences in treatment decisions can also help, according to Dr. Fox. He cited a study that found 81% of patients with IBD said it was “very important” that they be involved in their medical decisions [Gut. 2012;61(3):459-465]. The same study found that 46% said it was important for them and their doctors to have equal input when starting a new medication. Dr. Fox said that shared decision-making is most appropriate when choices exist, and patient preferences, not medical expertise, are paramount.

If patients have chronic disease, Dr. Fox said they should be treated with a team of doctors who coordinate treatment, provide clinical, behavioral, and supportive care and follow up and assess the condition and progress on a regular basis.

Cost-Effectiveness of Treatments

Jeffrey D. Dunn, PharmD, senior vice president at VRx Pharmacy Services, said that the cost-effectiveness of treatments should be considered when choosing the drugs to take. According to Artemetrx, a healthcare data analytics firm, per-member per-year (PMPY) spending on traditional drugs was $665 compared with $290 for specialty drugs. By 2018, PMPY spending will be $845 on specialty drugs and $836 on traditional drugs.

Data from CVS Caremark in 2011 showed that the largest specialty category is RA (23.9% of costs), followed by MS (18.0%), oncology (14.3%), HIV (10.9%), and human growth hormone (4.3%).

Dr. Dunn mentioned that managed care pharmacy’s goals are to incorporate the diagnosis, costs and treatment information with pharmacy data and integrate a patient’s medical history with their therapeutic regimen. He added that an expanded formulary leads to more access to drugs at a lower copay in the short-term, but the increasing pharmacy costs contribute to higher copays and premiums in the long-term.

To best evaluate what drug to choose, Dr. Dunn said managed care professionals need to assess the drug’s efficacy as well as its price. He noted that measures such as the cost per event avoided and the cost per percentage of improvement are effective, particularly when there are no head-to-head trials comparing the drugs.

Dr. Dunn also said that comparative effectiveness research can help as an alternative to head-to-head trials. Although the Patient Protection and Affordable Care Act contains several provisions related to comparative effectiveness research, the concept is not new, according to Dr. Dunn. He cited an Institute of Medicine report from 2009 that defined comparative effectiveness research as assessing the benefits and harms of different methods to prevent, diagnose, treat, and monitor a clinical condition or improve care delivery.

When referring to effectiveness, Dr. Dunn meant does the treatment work for an average person in an average practice rather than in randomized controlled trials. The method is effective at comparing health or economic outcomes, patient preferences, and adverse events.

Dr. Dunn added that pharmacy benefit managers can manage the increasing specialty drug spend through medication therapy management, utilization reviews, and closed formularies.