The number of drugs to treat cancer in the drug development pipeline, reportedly exceeding 900 as of 2012,1 is both exciting and frightening to payers. Nearly half of the cancer medications currently in development are oral oncolytics, and with costs for these agents commonly exceeding $50,000 to $100,000 per patient per year, this could result in significant budgetary impacts for payers. There is no question that innovation can result in improved quality of care and reduction in morbidity and mortality rates for various cancers; however, payers struggle with ensuring that the right patient receives the right medication at the right time.
In the case of expensive self-administered medications, this also means ensuring that patients prescribed the right medication take the medication as prescribed and are adherent to the therapeutic regimen. This is easier said than done. An analysis of patients diagnosed with early-stage breast cancer showed that less than 50% of patients prescribed adjuvant hormonal therapy actually continued therapy for the full duration of the optimal schedule for treatment.2 The same analysis showed that younger patients were even more nonadherent to therapy than older patients. Reasons for nonadherence included lack of patient counseling by their physician, toxicity from the therapeutic regimen, and out-of-pocket costs associated with the prescribed therapy.
In addition to lack of adherence (failure to take the medication as prescribed), common challenges also include failure in filling the initial prescription (noninitiation) and failure to continue the prescribed duration of therapy (early discontinuation).3 Many strategies have been used to improve rates of adherence to self-administered therapies, including oral therapies, in the past. This article will shed light on a strategy requiring more frequent counseling of patients by patient care coordinators trained in oncology and the partnership they form with the patients to ensure improved adherence to potentially life-saving therapies.
Cost Trend Mitigation Strategies for Oral Oncolytics
While traditional drug cost trends are forecasted to be in the range of 0% to 5% per year over the next 2 years, specialty drug cost trends are expected to be in the range of 20% to 25% per year during the same time period.4 In response to historical and forecasted drug cost trends for specialty drugs, payers have implemented various strategies to help mitigate these cost trends.
Strategies that have been and continue to be implemented include renegotiating contracts with providers to obtain more aggressive discounts, benefit cost strategies aimed at shifting more costs to patients through increased cost sharing, formulary management strategies aimed at a low net cost goal through preferencing of lower cost agents and/or obtaining larger rebate concessions from pharmaceutical manufacturers, utilization management strategies including step therapy and/or prior authorization to ensure medications are being prescribed in accordance to best practices and consensus guidelines, channel management strategies to ensure medications are dispensed or administered in the lowest cost site of care, and drug therapy management strategies to ensure patients are taking the most appropriate therapies and remaining adherent to prescribed therapies.
Innovation in all of these areas has been experienced over the past few years. One of the most recent innovations within drug therapy management, partial fill strategies for oral oncolytics, has led to some excitement within the payer and specialty pharmacy communities due to its impact on drug cost trends as well as improved, and more frequent, direct interaction between providers and the patients they are treating.
Partial Fill Strategies for Oral Oncolytics
The first published article on partial fill strategies for oral oncolytics focused on 3 oral oncolytics, including sorafenib (Nexavar), sunitinib (Sutent), and erlotinib (Tarceva).5 In this program, monthly therapies for the 3 medications were split into 14-day and 16-day batches (partial fill) and out-off-pocket cost share was also adjusted for the partial fill. In addition to the partial fill of the prescription, patients received education on the treatment regimen, the importance of adherence to therapy, and earlier identification of adverse events from the medications, and regular communication with the patients and their providers on measures to take to reduce dosages or discontinue therapy was provided.
The intervention group consisted of 1069 patients who were prescribed 1 of the 3 study medications during the time period of June 2008 through February 2010. The control group consisted of 351 patients who were prescribed 1 of the 3 study medications during the time period of January 2007 to May 2008 (before the inception of the partial fill program).
The authors demonstrated that 261 patients discontinued therapy in the first month of the program, and 7.7% could have saved at least one-half of the prescribed month of therapy. Overall, 33.8% of patients could have been prevented from wasting the prescribed oral chemotherapy medications through implementation of a partial fill program. Average savings per patient was $934.20. The study also demonstrated that hospitalizations were reduced by 2.9%, resulting in average savings of $439.87, in patients that received interventions within the partial fill program.
The results of this study have led to a rapid expansion of partial fill strategies being adopted by payers and an expansion in the number of oral oncolytics included in the partial fill programs.
Expansion of Partial Fill Strategies for Oral Oncolytics
In early 2010, Diplomat Specialty Pharmacy implemented a partial fill program for payer clients focusing on enhanced outreach, education, and intervention for patients that were prescribed sorafenib (Nexavar), sunitinib (Sutent), or erlotinib (Tarceva). Patient outreach was provided telephonically twice per month by patient care coordinators, nurses, and pharmacists with specific training in oncology. Each phone call was provided 5 to 7 days before the next partial fill was dispensed. Dispensing was provided in 14-day and 16-day batches.
Patient outreach included initial enrollment of the patient into an oncology patient care program, education of the patient on their diagnosis and prescribed therapy which included verbal communication as well as written education materials, assessment of adverse events reported by patients and what to do to mitigate adverse events, copay assistance support provided through non-profit charitable organizations, home delivery of prescribed medications and supportive therapies, and outreach to prescribing physicians to discuss alternative treatment options for patients that could not tolerate the prescribed therapy.
Results of interventions were tracked for 12 months after the program was implemented (). Nearly 43% of patients discontinued therapy after the first month of the prescribed therapy with nearly 25% discontinuing therapy after 1 partial fill. The primary reason for discontinuation was adverse events reported by patients.
Based on the results of the initial partial fill program rollout, the list of target medications for the program was expanded in early 2011 to include sorafenib (Nexavar), sunitinib (Sutent), erlotinib (Tarceva), everolimus (Afinitor), imatinib (Gleevec), dasatinib (Sprycel), bexarotene (Targretin), and pazopanib (Votrient). The same types of interventions were provided to patients in this phase of the program. Results of interventions were tracked for 12 months after the program was implemented (). Fifty-two percent of patients discontinued therapy after the first month of the prescribed therapy, with more than 15% discontinuing therapy after 1 partial fill. The primary reason for discontinuation in this phase was adverse events reported by patients.
The current version of the partial fill oral oncolytic program includes 15 oral oncolytics (). The program was expanded to include all 15 oral oncolytics in early 2012. Specific oral oncolytics were targeted for the program due to high discontinuation rate due to poor response, adverse effects, and high rates of noncompliance. Results of interventions were tracked for 9 months after the program was implemented (). 41% of patients discontinued therapy after the first month of the prescribed therapy with approximately 20% discontinuing therapy after 1 partial fill. Again, the primary reason for discontinuation in this phase was adverse events reported by patients.
In addition to tracking discontinuation rates of therapy, potential drug cost savings has also been tracked (). For a payer that has approximately $1M in annual spend for the targeted medications, the potential annual savings due to this program would be expected to exceed $186,000 or 19% of total spend based on the average monthly cost of the prescription and the experienced discontinuation rates.
It is important to note that the purpose of partial fill oral oncolytic programs is not to reduce access to potentially lifesaving therapies. The goal is to allow more frequent direct intervention and tracking of patients and their therapies by personnel specifically trained in oncology. The patient care coordinators, pharmacists, and nurses working within specialty pharmacies that reach out to patients regularly partner with patients and their physicians to promote high-quality care and improved adherence to therapy. While significant drug cost savings can be achieved with partial fill oral oncolytic programs, the focus must remain on the patient and ensuring that they are getting the best care possible.
In conducting these programs, there are 2 observations that require more study and understanding. One observation is related to the higher-thanexpected rate of adverse events with the therapies. The incidence reported by patients was higher than that reported in clinical trials with these therapies and this should be investigated more thoroughly. The other observation was the incidence of mortality in patients within each phase of the program, which reached over 20% of patients that discontinued therapy after the first month of treatment. This also needs further investigation to ensure that the specific medications are not being used in lieu of end-of-life care for patients. The answers to these questions will further our understanding of these important therapies and how they can impact the lives of patients diagnosed with cancer.Author Affiliation: From Diplomat Specialty Pharmacy, Flint, MI.
Funding Source: None.
Author Disclosure: The author reports no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.
Authorship Information: Concept and design; acquisition of data; analysis and interpretation of data; and drafting of the manuscript.
Address correspondence to: Atheer A. Kaddis, PharmD, Senior Vice President, Sales and Business Development, Diplomat Specialty Pharmacy, 4100 S Saginaw St, Flint, MI 48507. E-mail: firstname.lastname@example.org. Medicines In Development — Cancer. 2012 Report. PhRMA. www.phrma.org/sites/default/files/1000/phrmamedicinesindevelopmentcancer2012.pdf. Accessed December 17, 2012.
2. Hershman DL, Kushi LH, Shao T, et al. Early discontinuation and nonadherence to adjuvant hormonal therapy in a cohort of 8,769 early-stage breast cancer patients. JCO.
3. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487-497.
4. Express Scripts Drug Trend Report 2011.http://www.drugtrendreport.com/specialty/specialty-forecast. Accessed January 6, 2013.
5. Khandelwal N, Duncan I, Ahmed T, et al. Impact of clinical oral chemotherapy program on wastage and hospitalizations. Am J Manag Care. 2011;17(5 spec no.):e169-e173.