Pharmacy News April 2016 Drug Guide and Clinical Program Updates Prime Therapeutics® Pharmacy and Therapeutics (P & T) Committee in association with Blue Cross and Blue Shield of Alabama’s Formulary Business Committee recently approved updates to the Drug Guides and made clinical program changes to select medications. All information is online at AlabamaBlue.com/pharmacy. The Prime Therapeutics P & T Committee ‐‐ consisting of doctors, pharmacists, and other healthcare professionals ‐‐ advises and makes recommendations based on clinical appropriateness. The Blue Cross and Blue Shield of Alabama Formulary Business Committee makes final approval of these clinical recommendations before implementation.
The following drugs may have coverage changes that affect what a member will be required to pay at the time of purchase. Members will receive a letter if they are negatively affected by a formulary change that is not a result of a new generic being available.
Prescription Drug Guide Updates – Effective April 1, 2016 (unless otherwise noted) Brand Name (generic name if available)
Therapeutic Class
Description of Change
Additional Comments
Avodart (dutasteride)
Prostatic Medications
Move from Tier 2 to Tier 3
Effective 12/18/15 generic equivalent now available
Cotellic
Anticancer Medications
Add to Tier 2
Effective 11/22/15
Daklinza
Antiretrovirals
Add to Tier 2
None
esomeprazole
Ulcer Drugs
Add to Tier 1
Effective 2/12/16
Gleostine 5mg capsules
Anticancer Medications
Add to Tier 2
Effective 11/15/15
Nexium (esomeprazole)
Ulcer Drugs
Move from Tier 1 to Tier 3
Effective 2/12/16 – generic equivalent now available
Ninlaro
Anticancer Medications
Add to Tier 2
Effective 11/30/15
Praluent
Cholesterol‐Lowering Medications
Add to Tier 2
None
Repatha
Cholesterol‐Lowering Medications
Add to Tier 2
None
Serevent Diskus
Bronchodilators
Add to Tier 2
None
Strensiq
Metabolic Medications
Add to Tier 2
None
Synjardy
Antidiabetic Medications
Add to Tier 2
None
Tagrisso
Anticancer Medications
Add to Tier 2
Effective 11/22/15
Tresiba
Insulin
Add to Tier 2
None
The Prescription Drug Guide is updated quarterly. Please visit AlabamaBlue.com/pharmacy for the most up‐to‐date information. Note: Coverage is subject to each member’s specific benefits. Group‐specific policies will supersede these policies when applicable. Please refer to the member’s benefit plan.
Clinical Program Updates – Effective April 1, 2016 (unless otherwise noted) The following medication dispensing limits (DL), prior authorization (PA), predetermination (PD) and/or step therapy (ST) programs have been added or revised:
New or Revised Pharmacy PA or ST Programs Policy Name
Type of Policy
Buprenorphine and Buprenorphine/Naloxone for Opioid Dependence
PA/DL
Hereditary Angioedema
PA/DL
Hepatitis C Second Generation
PA
Kalydeco/Orkambi
PA/DL
Keveyis
PA/DL
Neprilysin Inhibitor (Entresto)
PA/DL
Oral Pulmonary Hypertension Agents
PA/DL
Opioids IR
DL
Oxycodone ER
DL
Coverage Criteria and Changes REVISED Provider certification to prescribe the targeted agents will now be verified upon submission of the request and initial authorizations for induction and stabilization will be limited to 2 months. Documentation will be required from the provider in the form of chart notes or records to support the presence of an active opioid dependence diagnosis, treatment plan, and counseling as indicated. As these agents are not covered for the treatment of pain, any claims for opioids will reject while a patient is receiving one of the targeted agents (e.g., Suboxone). Coverage of opioids for acute pain or procedures will require prior authorization. Patients should also not be receiving any other addictive medications (including benzodiazepines) unless the provider submits documentation that the benefits outweigh the risks. Additionally, patients will only be allowed to receive one buprenorphine containing product in a single strength at a time unless undergoing a dose taper. Quantity limits have been adjusted for buprenorphine to allow for 1‐ 3 days of induction therapy (5 tablets). Limits for buprenorphine/naloxone products to allow up to 16 mg of buprenorphine, with the ability for a provider to document the need for a higher dose (24 mg) through the PA process. REVISED Policy updated to require the provider to indicate the patient does not have more than a 1 month supply of drug. REVISED – Policy updated to allow coverage for genotype 4, 5, and 6 based on FDA labeling. The policy also requires treatment experienced genotype 1 patients with cirrhosis to use Harvoni and ribavarin for 12 weeks instead of Harvoni monotherapy for 24 weeks (unless the patient is ineligible for ribavarin). REVISED Coverage for Orkambi will be allowed for patients who have the F508del mutation on both alleles confirmed by genetic testing or who have another FDA approved indication. Coverage for Kalydeco will be allowed for patients who have one of the CFTR gene mutations indicated in the FDA label confirmed by genetic testing and have one copy of the F508del mutation or who have another FDA approved indication. NEW Coverage will be allowed for patients with a diagnosis of primary hypokalemic or hyperkalemic periodic paralysis. The patient must have tried and failed acetazolamide and have implemented and maintained dietary life style changes to decrease paralysis episodes. If approved, the quantity limits are 4 tablets per day. NEW Coverage will be allowed for patients with Stage II‐IV heart failure who have a reduced baseline or current ejection fracture ≤ 40% who are on a beta blocker drug or who are unable to take a beta blocker drug. If approved, quantity limits are 2 tablets per day. Current users will be allowed to continue therapy. REVISED Addition of Uptravi to the program. Coverage will be provided for patients who have a diagnosis of pulmonary arterial hypertension and whose therapy falls within product labeling and clinical guidelines. If approved, the quantity limits are 60 tablets per month. The quantity limits for Orenitram were also removed. REVISED – To obtain quantities above the set quantity limits, the patient must have a diagnosis of active cancer pain due to an active malignancy, the prescriber must confirm that the patient is on a specific pain management plan, and the prescriber must verify through the prescription drug monitory program that the patient is not diverting the requested medication. REVISED – To obtain quantities above the set quantity limit, the patient must have a diagnosis of active cancer pain due to an active malignancy, the prescriber must confirm that the patient is on a specific pain management plan, and the prescriber must verify through the prescription drug monitory program that the patient is not diverting the requested medication.
New or Revised Dispensing Limits Brand Name (generic if available)
Strength
Dispensing Limit per month
New or Revised
Alecensa Fetzima Titration Pak
150 mg 20mg, 40mg
NEW REVISED
Narcan Nasal Spray
4mg/0.1ml
Ninlaro Pradaxa Rebif Titration Pak
2.3mg,3mg,4mg 110 mg 8.8 mcg/0.2ml, 22mcg/0.5ml
240 1 kit (28 capsules)/180 days 1 package (2 nasal sprays) per 365 days 3 capsules/28 days 60 tablets 1 kit/180 days
NEW NEW NEW REVISED
Clinical Program Updates – Effective April 1, 2016 New or revised physician‐administered (medical) drug programs Policy Name
Type of Policy
Botulinum Toxin
Medical PD
Hereditary Angioedema (HAE)
Medical PD
Injectable Asthma Agents
Medical PD
IV Multiple Sclerosis
Medical PD
Viscosupplements Vivitrol
Xolair
Medical PD Medical PD Medical PD
Coverage Criteria and Changes REVISED – Policy updated to clarify blepharospasm must be associated with dystonia; standard/accepted chronic migraine definition updated; renewal criteria added for all diagnoses with 12‐month approval unless the provider requests shorter therapy; clarified criteria concerning strabismus; changed urinary incontinence diagnosis to overactive bladder with symptoms specified in policy; removed oral medication prerequisite requirement for hyperhidrosis diagnoses. REVISED – Policy updated to clarify testing requirements. Renewal criteria and language to ensure communication is taking place between provider and patient regarding frequency/severity of attacks is added. NEW – Policy implemented to manage new drug, Nucala, in patients with severe eosinophilic asthma. This policy will require that the patient is currently receiving maximally tolerated inhaled corticosteroids plus a controller medication and the dose of Nucala is within FDA maximum dose. Renewal criteria are also included. REVISED – Policy updated to allow use of Tysabri for MS when patient has previously used Lemtrada. Renewal criteria for Tysabri in Crohn’s disease to show clinical benefit for treatment continuation and to not allow two DMA’s. REVISED – Policy updated to include Supartz FX. REVISED – Policy updated to add requirement for opioid dependence that patient be opioid free for at least 7 days. Renewal criteria added to program. REVISED – Criteria updated to require that patient is treated with an inhaled corticosteroid and one additional controller medication unless patient ineligible to receive. Definition of uncontrolled asthma updated to match national guidelines.
Management of Buprenorphine and Buprenorphine/Naloxone for Opioid Dependence By partnering with our Behavioral Health vendor New Directions and our Pharmacy Benefit Manager (PBM) Prime Therapeutics, we are using an integrated management approach to achieve better outcomes and quality of care for patients suffering from addiction to opioids (e.g., heroin, prescription pain medications). If the employer group delegates Behavioral Health services to Blue Cross, their members will benefit from case management and referral services through New Directions when receiving buprenorphine or buprenorphine/naloxone products for opioid dependence that had not been available previously.
In an effort to reduce costs associated with inappropriate drug utilization, multiple updates will be made to the existing Buprenorphine and Buprenorphine/Naloxone for Opioid Dependence Prior Authorization program and review process starting on April 1, 2016. This is not a benefit change and applies only to employer groups who participate in our standard Preferred Utilization Management (UM) package. Any existing authorizations for buprenorphine, buprenorphine/naloxone, Suboxone, Bunavail, or Zubsolv will remain valid through the authorization end date. Upon expiration of those authorizations, renewal requests will be subject to the updated program criteria. Once the program is implemented, members with the potential for negative impact will be grandfathered through 6/30/16. Impacted members will receive notification letters starting in May 2016. AccessONE Network Prime Therapeutics added a new pharmacy network beginning January 1, 2016. The AccessONE Network consists of a 30‐day retail network and a 90‐day extended supply network. Extended supply networks offer an alternative to home delivery. Members can fill a 90‐day supply of long‐term (maintenance) medicines at participating extended supply retail pharmacies. Over 30,000 pharmacies participate in the AccessONE Network. Not all major pharmacy chains are included in this network. Certain major pharmacy chains such as Walgreens, Walmart and RiteAid do not participate in this network. Participating pharmacies are listed on our website AlabamaBlue.com/pharmacy.
Physician‐Administered Drug Review The Physician‐Administered Drug Review program for managing medical drugs will go into effect as plans renew throughout 2015 and early 2016. The Physician‐Administered Drug Review program, once deployed on April 1, 2016, will require a precertification in order to evaluate all physician‐administered drugs with an applicable medical policy. Currently, physician‐administered drug claims are reviewed against medical policy to determine coverage, but this primarily occurs after the drug has been administered (i.e., post‐service review). Precertification will require that member eligibility and drug coverage be verified against any existing medical policy requirements prior to administration of the drug. The new precertification Physician‐Administered Drug Review program will provide the following benefits:
More consistent application of medical policy requirements to identify inappropriate use, inappropriate dose, safety concerns or other coverage issues before the drug is administered Improved member safety, minimization of waste and reduction in cost associated with inappropriate therapy Earlier notification of coverage issues which helps us deliver superior customer service and meet the high standards of accreditation Group level utilization reporting will be made available after implementation
Medical drug policies have been updated and are accessible online at AlabamaBlue.com/pharmacy by selecting “Physician‐Administered Drug Policies and Forms.” Physician‐administered drug policies are a component of utilization management programs for drug therapy provided in the physician’s office or other outpatient settings. Physicians are beginning to use our new online tool for the submission of precertification review requests to provide administrative efficiencies and limit the turn‐around time for coverage determinations. The existing post‐service review process will not be maintained after April 1, 2016. If a group elects to defer Physician‐Administered Drug Review, no utilization management will apply to physician‐administered drugs. Since physician‐administered drug claims would not be subject to a precertification or post‐service review, an increase in claim payments may occur. Letters have been mailed to affected members and their providers.
Drug Exclusion Strategy To help manage the rising cost of drugs, the drug exclusion strategy is available for our self‐funded and merit business. Drug exclusion strategies limit or non‐cover targeted drugs from a group’s coverage. Most of the drugs that are limited or non‐covered are expensive and often have lower‐cost drug alternatives available. This strategy also helps encourage utilization of generics and formulary drugs. When a group elects to implement the drug exclusion strategy, it will include the drug categories listed below. Drug Categories Androgen/Anabolic Steroids Doxycycline/Minocycline Growth Hormones Insomnia Nasal Steroids Test Strips Topical Antibiotics Topical Retinoids Benefits of the Drug Exclusion Strategy: Estimated savings and member disruption reporting will be available Groups will have a savings opportunity by locking out specific high‐cost drugs from coverage New drug categories, targeted agents, and preferred agents may be added on an annual basis Combats coupons that encourage utilization of expensive non‐formulary drugs A notification including a list of excluded drugs and available alternatives will be mailed to members affected by the drug exclusion strategy. Our prescription drug search, available post‐login on AlabamaBlue.com, will indicate which medicines are not covered and provide information on available alternatives.