Teva launches generic drug for cystic fibrosis patients
JERUSALEM — Teva Pharmaceutical Industries has launched its generic version of a drug for patients with cystic fibrosis, the Israeli drug maker said Thursday.
Teva announced the launch of tobramycin inhalation solution, a generic version of Novartis’ drug Tobi. The Food and Drug Administration approved Teva’s product last month. The drug is used to treat CF in patients whose lungs contain bacteria called Pseudomonas aeroginosa.
Tobi had sales of about $350 million during the 12-month period that ended in June, according to IMS Health.
Quality key to value-driven health care
Health care has begun to emphasize quality in addition to cost as a means to provide what is known as value-driven health care. Of particular interest is the increased recognition of the value of the pharmacist’s role as a member of the healthcare team. Pharmacists are medication experts and have demonstrated success in improving the quality of medication use, especially as it relates to such key quality metrics as high-risk medications, or HRM, in the elderly; adherence as measured by the proportion of days covered; and the movement of patients with diabetes to the appropriate hypertension medication.
The Centers for Medicare and Medicaid Services, or CMS, established a five-star quality rating system a few years ago to educate consumers. The Patient Protection and Affordable Care Act ties reimbursement rates to performance as measured by the star rating system. Updated CMS star measures or ratings are available to all Medicare members prior to open enrollment. There are added incentives to attract patients to higher quality plans. For example, five-star plans can offer enrollment to patients year round, not just during open enrollment. To learn more quality measures, the following websites are recommended for review:
- CMS.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/Downloads/2014-Draft-Tech-Notes.pdf; and
There are numerous ways in which the profession has defined the quality of medication use, and pharmacy is key in the metrics designed for medication use. The star-measures specifically related to medication management and use will demonstrate how pharmacists can impact the overall rating through patient-centered care.
The star-measures looks at three specific areas — diabetes, cardiovascular, and cholesterol — relative to adherence measures. While there have been numerous methods designed to measure adherence in the past — such as medication possession ration, or MPR — the current measurement used is the proportion of days covered, or PDC. MPR has sometimes been criticized as overestimating the true rate of medication adherence. There are variations in the calculation of the PDC; however, PDC is considered to be more consistently defined than the MPR, according to the Pharmacy Quality Association. The calculation to achieve PDC is based on the fill dates and days supply for each fill of a prescription; however, it is not a simple summation of the days supply.
Health plans, PBMs and CMS are using the PDC calculation in determining the adherence rates of patients, as well as how patients from various pharmacies are managing their medications. Many payers have been tracking adherence of their beneficiaries for years, but recently began specifically looking at individual pharmacies to determine who is providing higher patient-centric quality care.
In addition to adherence, medication safety is focus for measuring quality in pharmacy. Use of HRMs is a key area of review for CMS. HRM is the percentage of patients older than 65 years who received two or more prescription fills for a high-risk medication during the measurement period — typically a 12-month period. The CMS star ratings for a plan to meet the HRM quality goal in 2013 was 5% or lower. This means that only 5% of patients should be on the medications that are considered high-risk. CMS has changed this metric for 2014 to 3%, which is the single-largest change seen in one metric. This is seen as an important measure to improve outcomes in elderly patients. Pharmacists are the gatekeepers to preventing the use of HRM in elderly patients. This medication safety metric does not prohibit a patient from taking some of the medications on the list, but instead reviews the usage over time. Table 1 provides a list of HRMs currently screened for this quality metric. Most pharmacists are familiar with the “Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.” The Beers Criteria now is maintained by the American Geriatrics Society, whereas the HRM list, and corresponding NDC code list, is maintained by PQA and includes only the subset of Beers medications that can be tracked reliably by prescription drug claims data.
Another medication safety metric provides pharmacists with opportunities to assist patients with diabetes to the appropriate ACE/ARB for hypertension. This metric underscores the appropriate medication selection to minimize harm to organs in patients with diabetes.
Of interest is the complexity of the two medication safety metrics. Both of these metrics rely heavily on pharmacists working with patients and prescribers. Unlike with adherence, where a pharmacist can help a patient become more adherent to therapy, these metrics cannot be impacted by just one individual. There is now, more than ever, a need for appropriate communication between all of the patient’s healthcare providers. HRM is a challenging measure, as the approach to improve this specific metric will require a multidisciplinary approach for pharmacists, patient, physicians and other prescribers.
In addition to the current CMS metrics, there are a number of display measures that have been developed by PQA and are being tackled. These include drug-drug interactions; excessive doses of oral diabetes medications; comprehensive medication review, or CMR; completion rate; and HIV antiretroviral medication adherence (only in safety reports). Additional metrics that are being used by some plans include asthma metrics for overuse of SABAs or under-use of maintenance medications.
To address a number of the metrics there has been a move toward partnerships for quality with plans, or PBMs, and community pharmacy. It is becoming more apparent that community pharmacy will be asked to assist plans and PBMs in moving toward obtaining a higher star rating. This is demonstrated in a number of developments. A health plan in Southern California is offering a pay for performance, or P4P, program for community pharmacies that have patients who are beneficiaries of the plan. The plan has in place specific metrics — CMS five star, asthma and others — that the pharmacies can reach and receive a payment every six months. These quality bonus payments are a way for the plan to provide additional reimbursement to those pharmacies that provide the highest level of patient-centric care, and who are tracking their progress on the metrics. This specific plan is partnering with Pharmacy Quality Solutions, or PQS, to use the Electronic Quality Improvement Platform for Plans and Pharmacies, or EQuIPP.
Globally, PQS tracks quality metrics for specific plans. Pharmacies may engage with PQS to access the EQuIPP platform, which shows them specifically where they stand on each of the quality metrics relative to the goals of a given plan (or CMS five-star goals), whether that is for adherence rates, medication safety initiatives or other metrics. The EQuIPP platform allows pharmacists to “Know Your Numbers” — how well performance is recorded relative to quality metrics.
Plans also are reviewing the current preferred network processes that they use. While historically cost has been a driving factor in the preferred networks, moving forward plans are looking to move to a quality and cost system. Plans are looking to those pharmacies that can drive them to a five-star status — the highest rating possible. Pharmacies that can provide five-star services to plan beneficiaries will be looked upon more favorably than those that provide lower star ratings
What impact do the quality metrics have on patient-centered care? Pharmacists are now being looked upon to apply clinical training across the board in community settings to drive quality. While this may not be happening in each and every practice, we are seeing the beginnings of a movement across the profession and specifically in community settings. Pharmacists are in a position to engage patients not only on the quality metrics to adherence and medication safety, but also transition of care, MTM services and other clinical-based disease state programs. All of these efforts to improve the patients’ medication-use quality result in better disease state management, adherence rates and patient understanding.
Enlisting patients in the drive to improve Rx
Nowhere is the need to engage more effectively with patients more apparent than in the area of medication adherence.
“Over 50% of patients with chronic conditions stop taking their medications,” said Diane Gilworth, a geriatric nurse practitioner and chief clinical officer for Dovetail Health. “So we have to find a way to help patients take better care of themselves.”
The health system’s dismal record for effectiveness in getting patients to adhere to their drug regimens prompted GlaxoSmithKline to overhaul its approach to encouraging adherence and to create a new business unit, called the Patient Engagement Group.
“We were doing things like refill reminders and text messages. We’re really good at patient education, at pushing leaflets and alerts to patients. But with all those rational solutions, we were completely missing the irrational behavioral part of nonadherence,” said Christy Brown, a pharmacist who directs patient engagement efforts at GSK as head of insights and innovation.
“How do we get people more engaged and more active in their health? … That in turn will lead to better adherence,” she said.
In response, GSK shifted its marketing focus “from a very product-focused, information-based, one-way conversation to a more behavioral-based approach … and giving providers some tools,” Brown said.
“We have to get into patients’ homes and understand, on a very granular, detailed level, what those behavioral characteristics are that are driving patients not to take their medications,” she said. “If we can reduce the readmission rate and lower total medical expense, then people will understand there’s a value here. And they’ll be willing to pay for longitudinal care.”
That shift, Gilworth added, “is a very big change because we used to think of things in very tight financial time frames. We have to extend that now, probably beyond the 30-day readmission incentives.”
That broader, more holistic, longer-term focus on health and outcomes, she said, is already beginning to occur among accountable care organizations. “ACOs are beginning to … understand that we have to take care of people over the long run, and that behavior, particularly in chronic disease, waxes and wanes,” Gilworth said. “How do you stay engaged when you’re trying to figure out how to eat?”