THE MOST FAVORED NATIONS MODEL INTERIM FINAL RULE IS FATALLY FLAWED AND MUST BE RESCINDED-YET THE PROBLEM IT ADDRESSES DEMANDS A SOLUTION.

DISCLOSURES: No funding supported the writing of this letter. The author has nothing to disclose.

Proposal to Reduce Adult Immunization Barriers in California.

Adult vaccination rates in the United States are consistently lower than the National Healthy People 2020 goals. Barriers to adult vaccination include inconsistency of insurance coverage of adult vaccines and difficulty in accessing vaccines. To help address the gap in adult access to vaccines, in 2016 the Department of Health Care Services--which administers the Medi-Cal program (California's version of Medicaid)--implemented the All Plan Letter (APL) 16-009, which requires coverage of recommended adult vaccines as a pharmacy benefit. Adult Medi-Cal patients can now receive the vaccines recommended for their age and underlying health conditions, and they can do so not only at a provider's office but also at local pharmacies, improving access and convenience. This policy brief recommends expanding coverage of all adult vaccines as a pharmacy benefit of all public and commercial insurance plans.

Letter--A Challenge to the Pharmacy Profession to Raise Its Voice on Health Care Reform.

DISCLOSURES: Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.

Letter--Draft FDA Guidance "Considerations in Demonstrating Interchangeability with a Reference Product": Overview and Presentation-Related Concerns.

DISCLOSURES: Rubinstein provides consulting services to the pharmaceutical industry, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. He was a participant on the Amgen Biosimilar Report Advisory Board and reports consulting fees from Amgen.

Grim Provider and Supplier Gross Margins of 1.8%-3.7% if CMS-1670-P Is Finalized As Proposed.

DISCLOSURES: The author provides consulting services to the pharmaceutical industry, including manufacturers, health plans, employers, and specialty pharmacies, and is a member of the editorial advisory board of Specialty Pharmacy News. The author reports no financial or other conflicts of interest related to the subject of this letter.

Evaluation of increased adherence and cost savings of an employer value-based benefits program targeting generic antihyperlipidemic and antidiabetic medications.

BACKGROUND: A major employer implemented a change to its employee health benefits program to allow beneficiaries with diabetes or high cholesterol to obtain preselected generic antidiabetic or generic antihyperlipidemic medications with a zero dollar copayment. To receive this benefit, plan beneficiaries were required to participate in a contracted vendor's case management and/or wellness program.  OBJECTIVE: To assess changes in medication adherence and the costs for generic antidiabetic and generic antihyperlipidemic medications resulting from participation in a zero copay (ZCP) program.   METHODS: This was a retrospective pre-post comparison group study, evaluating adherence and cost. Participants using an antihyperlipidemic and/or antidiabetic medication during the study identification period and post-implementation period for the program were considered eligible for the study. Eligible beneficiaries who enrolled in the ZCP program during the post-implementation period were considered participants, while those who did not enroll during this period were considered nonparticipants. ZCP program participants and nonparticipants were matched via a 1-to-1 propensity scoring method using age, gender, comorbidity count, medication type (antihyperlipidemic, antidiabetic, or both), and baseline adherence as matching criteria. The proportion of days covered (PDC) metric expressed as a mean percentage was used to assess adherence to medication therapy, while payer cost was examined using prescription drug utilization expressed as per member per year (PMPY) and cost change per 30 days of medication expressed in dollars.   RESULTS: Among participants who were users of antidiabetic medications, the mean adherence rate was sustained from pre- to post-implementation (81.8% vs. 81.9%); however, it decreased in the matched nonparticipant group (81.9% vs. 73.1%). This difference in mean adherence over time between the participants and nonparticipants was statistically significant (0.1% vs. -8.8%, P less than 0.001). Similar results were found among users of antihyperlipidemics. The mean adherence rate was sustained over time for participants (77.7% vs. 78.3%) but declined over time for nonparticipants (77.6% vs. 70.8%). The difference in mean change over time was statistically significant between participants and nonparticipants (0.6% vs. -6,8%, P less than 0.001). Average prescription costs PMPY increased for participants of the ZCP program during the post-implementation period; however, the increase was not larger than the cost increase among nonparticipants ($581 vs. $584, P = 0.95). Furthermore, among antihyperlipidemics the cost increase post-implementation was actually significantly less for participants than nonparticipants ($51 vs. $143, P less than 0.001).  CONCLUSIONS: Plan sponsors are increasingly evaluating the use of value-based benefit design (VBBD) to change member behavior. This ZCP program used a reduction in cost sharing to incentivize members to use more generic drugs and to enroll in a care management coaching program. The study also demonstrated that a VBBD program can have a positive impact on adherence and cost outcomes among those who participate compared with nonparticipants. 

Oral chemotherapy program improves adherence and reduces medication wastage and hospital admissions.

Adherence, medication wastage, and reduction in hospital admissions were investigated in a retrospective test-control study design for patients enrolled in the oral chemotherapy cycle management program (CMP), a program that offers clinical support, dose monitoring, and early identification of side effects for patients on select oral chemotherapy. Patients who initiated oral chemotherapy with sorafenib, sunitinib, or erlotinib during June 2008 through December 2009 and who were enrolled in the CMP were included as a test group. Patients who initiated oral chemotherapy with these drugs using Walgreens Specialty Pharmacy during January 2007 through May 2008 and were not part of the CMP were included as control group 1, and patients from a national payor database who initiated therapy with sorafenib, sunitinib, or erlotinib during June 2008 through August 2010 were included as control group 2. Compared with control group 1, patients in the CMP group showed no significant differences with regard to their possession ratios (P > .05), but demonstrated significantly higher persistency rates (P < .05) at the end of 6 months follow-up. For patients in the CMP group who discontinued therapy, approximately 34% could have experienced reduced wastage had they been on a split medication plan. Patients who are monitored closely and able to identify serious side effects early can avoid complications leading to hospitalizations. The study showed potential savings on drug costs because of a split-fill medication plan, and savings from reduced hospitalization associated with timely identification and management of severe side effects. A clinical program, such as CMP, effectively improves adherence and reduces wastage and hospitalizations for oral chemotherapeutic agents, realizing potential cost savings to both payors and patients.

Community pharmacy and mail order cost and utilization for 90-day maintenance medication prescriptions.

BACKGROUND: Pharmacy benefit management (PBM) companies promote mail order programs that typically dispense 90-day quantities of maintenance medications, marketing this feature as a key cost containment strategy to address plan sponsors' rising prescription drug expenditures. In recent years, community pharmacies have introduced 90-day programs that provide similar cost advantages, while allowing these prescriptions to be dispensed at the same pharmacies that patients frequent for 30-day quantities. OBJECTIVE: To compare utilization rates and corresponding costs associated with obtaining 90-day prescriptions at community and mail order pharmacies for payers that offer equivalent benefits in different 90-day dispensing channels. METHODS: We performed a retrospective, cross-sectional investigation using pharmacy claims and eligibility data from employer group clients of a large PBM between January 2008 and September 2010. We excluded the following client types: government, third-party administrators, schools, hospitals, 340B (federal drug pricing), employers in Puerto Rico, and miscellaneous clients for which the PBM provided billing services (e.g., the pharmacy's loyalty card program members). All employer groups in the sample offered 90-day community pharmacy and mail order dispensing and received benefits management services, such as formulary management and mail order pharmacy, from the PBM. We further limited the sample to employer groups that offered equivalent benefits for community pharmacy and mail order, defined as groups in which the mean and median copayments per claim for community and mail order pharmacy, by tier, differed by no more than 5%. Enrollees in the sample were required to have a minimum of 6 months of eligibility in each calendar year but were not required to have filled a prescription in any year. We evaluated pharmacy costs and utilization for a market basket of 14 frequently dispensed therapeutic classes of maintenance medications. The proportional share of claims for each therapeutic class in the mail order channel was used to weight the results for the community pharmacy channel. Using ordinary least squares regression models, we controlled for differences between channel users with respect to the following confounding factors: age, gender, presence or absence of each of the top 11 drug-inferred conditions (e.g., asthma/chronic obstructive pulmonary disease, cardiovascular disease), drug mix, and calendar year. We calculated estimated predicted means holding all covariates at their mean values. For both 90-day dispensing channels, we calculated number of 90-day claims per member per year (PMPY) and cost per pharmacy claim, with all claims counts adjusted to 30-day equivalents (i.e., number of 90-day claims × 3). Differences were compared using t-tests for statistical significance. RESULTS: Of 355 PBM clients prior to exclusions, 72 unique employers covering 644,071 unique members (range of approximately 100 to more than 100,000 members per employer) were included in the analysis. On an unadjusted basis, community pharmacies represented 80.8% of 90-day market basket claims (in 30-day equivalents: 3.97 claims PMPY vs. 0.95 in mail order) and 77.2% of total allowed charges. After adjustments for therapeutic group mix and patient characteristics, predicted mean pharmacy claim counts PMPY were 4.09 for community pharmacy compared with 0.85 for mail order (P less than 0.001). Predicted mean allowed charges per claim for community and mail order pharmacies did not significantly differ ($49.03 vs. $50.04, respectively, P = 0.202). CONCLUSIONS: When offered maintenance medications through community and mail order pharmacies on a benefit-equivalent basis, commercially insured employees and their dependents utilized the community pharmacy channel more frequently by a margin of more than 4 to 1 in terms of claims PMPY. Overall allowed charges per claim for community and mail order pharmacy did not significantly differ.

Medication adherence for 90-day quantities of medication dispensed through retail and mail order pharmacies.

OBJECTIVES: To examine relative medication adherence of patients filling 90-day supplies of maintenance medications using retail and mail order channels. It was hypothesized that adherence rates would not differ across the 2 channels. STUDY DESIGN: A cross-sectional retrospective analysis was conducted using de-identified pharmacy claims data from a large pharmacy benefit manager (PBM) database over a 2-year period (January 2008 to August 2010). Patients who were continuously eligible for at least 12 months during this time frame, with benefit plan designs that allowed filling of 90-day supplies either at retail or by mail order pharmacy, were selected. METHODS: Adherence was measured by medication possession ratio (MPR) within a 1-year period. Propensity score matching was employed to minimize differences between the Retail-90 group and Mail Order-90 group. RESULTS: Overall, patients filling 90-day prescriptions for 9 therapeutic groups (antiasthmatics and bronchodilators, antidepressants, antidiabetics, antihyperlipidemics, antihypertensives, beta blockers, calcium channel blockers, diuretics, and thyroid agents) at retail pharmacies demonstrated a propensity score­matched average MPR that was statistically higher than for patients filling prescriptions via mail order (77.0% vs 76.0%). There were no significant differences in MPR (post-matching) between 90-day retail and mail order channels for individual therapeutic groups, except for antidiabetics (80.2% vs 83.1%). CONCLUSIONS: On a propensity-matched basis, patients who fill maintenance prescriptions at retail have a slightly, but statistically significantly, higher MPR than patients who fill their prescriptions by mail

Impact of clinical oral chemotherapy program on wastage and hospitalizations.

PURPOSE: The oral chemotherapy cycle management program (CMP) provides clinical management support to patients receiving certain oral chemotherapies. The CMP includes a dose-monitoring (ie, split-fill) plan for early identification and management of adverse effects. If serious adverse effects are identified mid cycle, the remainder of the monthly supply is withheld, thus avoiding potential waste associated with early therapy discontinuation. This study investigated medication wastage and estimated potential cost savings for patients who were enrolled in the CMP, as compared with those who were not enrolled in the program. STUDY DESIGN: Retrospective test-control study. PATIENTS AND METHODS: Patients whose oral chemotherapy was initiated between June 2008 and February 2010 and who were enrolled in the CMP were included as the test group. Patient whose oral chemotherapy was initiated between June 2007 and May 2008 and who were not part of the CMP were included as the control group. RESULTS: Medication wastage associated with early therapy discontinuation was found to be lower in the CMP group. Approximately 34% of patients in the CMP group could have avoided medication wastage if split-fill plans had been available, potentially realizing savings of approximately $934.20 per patient. Linear probability regression models showed that the CMP group had a 2.9% probability for reduction in hospital admissions (P < .05), resulting in additional savings of approximately $440.0 per patient. Combined savings resulting from reduced wastage and hospital admissions was approximately $1,374 per patient. CONCLUSION: Dose-monitoring programs such as the CMP effectively reduce wastage and serious adverse effects associated with oral chemotherapeutic agents, realizing potential cost savings for both payers and patients.

Impact of clinical oral chemotherapy program on wastage and hospitalizations.

OBJECTIVE: The oral chemotherapy cycle management program (CMP) provides clinical management support to patients receiving certain oral chemotherapies. The CMP includes a dose-monitoring (ie, split-fill) plan for early identification and management of adverse effects. If serious adverse effects are identified mid cycle, the remainder of the monthly supply is withheld, thus avoiding potential waste associated with early therapy discontinuation. This study investigated medication wastage and estimated potential cost savings for patients who were enrolled in the CMP, as compared with those who were not enrolled in the program. STUDY DESIGN: Retrospective test-control study. PATIENTS AND METHODS: Patients whose oral chemotherapy was initiated between June 2008 and February 2010 and who were enrolled in the CMP were included as the test group. Patients whose oral chemotherapy was initiated between June 2007 and May 2008 and who were not part of the CMP were included as the control group. RESULTS: Medication wastage associated with early therapy discontinuation was found to be lower in the CMP group. Approximately 34% of patients in the CMP group could have avoided medication wastage if split-fill plans had been available, potentially realizing savings of approximately $934.20 per patient. Linear probability regression models showed that the CMP group had a 2.9% probability for reduction in hospital admissions (P <.05), resulting in additional savings of approximately $440.00 per patient. Combined savings resulting from reduced wastage and hospital admissions was approximately $1374 per patient. CONCLUSION: Dose-monitoring programs such as the CMP effectively reduce wastage and serious adverse effects associated with oral chemotherapeutic agents, realizing potential cost savings for both payers and patients.

Application of 'functional equivalence' to payment for office-administered biopharmaceuticals.

The emergence of competing biotech products has led to much discussion about their interchangeability. Beyond the clinical implications of designating products as therapeutically equivalent, the dollars at stake with biopharmaceuticals promise to make reimbursement issues more and more important. Medicare's approach could influence private payers, which have been slower to address these issues.