1. Promoting high quality, cost effective drug therapy throughout the Military Health System Prior Authorization & Medical Necessity Determinations in the Military Health System Shana Trice, PharmD, BCPS Libby Hearin, PharmD COL Dan Remund, USA

2. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 2 Outline Prior Authorizations (PAs) –Drug selection –Criteria development Types of Medical Necessity (MN) Determinations PA / MN process in TMOP & TRRx Portability of PA & MNs

3. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 3 Prior Authorizations Selecting Medications High risk of inappropriate use? –Lack of clinical evidence to support use –Evidence that a medication is ineffective for a given use –Use of a high cost agent when more cost-effective alternatives available Safety issues? TRICARE coverage issues? Would a PA be cost-effective? –High cost, substantial use, high risk of inappropriate use –Do direct costs exceed costs avoided? –Does existence of the PA cause providers to write fewer Rxs (the “sentinel effect”)

4. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 4 Prior Authorizations Development & Approval of Criteria PEC develops draft criteria & implementation plan –Expert opinion (Service consultants in specialty areas, surveys of MTF providers) –Industry practice –Practical to implement DoD P&T Committee reviews, comments on, recommends approval of criteria & implementation plan Director, TRICARE Management Activity (TMA) approves after considering comments from Beneficiary Advisory Panel PEC develops PA forms & other supporting documents in conjunction with ESI

5. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 5 Prior Authorizations Current PAs Phosphodiesterase-5 (PDE-5) inhibitors for erectile dysfunction (male pts < 50) –Sildenafil (Viagra), tadalafil (Cialis), vardenafil (Levitra) –Coverage issue (psychogenic vs. organic cause) –Inappropriate use (e.g., recreational, diversion) –HA policy 98-040 recently rescinded –QL (6 per month) still in place, PA for males < 50

6. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 6 Prior Authorizations Current PAs Biologic agents for arthritis/psoriasis –Etanercept (Enbrel), adalimumab (Humira), anakinra (Kineret), and efalizumab (Raptiva) –High cost, new therapies, FDA indications tightly track available evidence

7. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 7 Prior Authorizations Current PAs Fertility agents (injectable gonadotropins) –Coverage issue – coital vs. noncoital use (Artificial Reproductive Technology) 32 CFR 199.4 (e)(34) - excludes services and supplies related to artificial insemination, in-vitro fertilization, gamete intrafallopian transfer and all other non-coital reproductive technologies 32 CFR 199.4 (e)(3)(B)(3) - family planning benefit does not include services and supplies related to noncoital reproductive technologies –Reflects clinical standards when regulations written

8. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 8 Prior Authorizations Current PAs Antifungals for onychomycosis –Ciclopirox (Penlac Nail Lacquer), itraconazole capsules (Sporanox), terbinafine tablets (Lamisil) –Safety, inappropriate use, high cost –Illogical to risk adverse effects and incur cost treating non-fungal conditions with an antifungal

9. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 9 Prior Authorizations Current PAs Growth hormone –Went into effect 1 June 2004 for new patients only –Coverage issue: FDA approved for Idiopathic short stature (ISS), but TMA concluded that treatment of ISS is not medically necessary –Inappropriate use: Use for other conditions not supported by the medical literature (e.g., depression, aging, weight control)

10. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 10 Types of Medical Necessity Determinations 1.To provide non-formulary medication at the formulary copay in TMOP or TRRx 2.To provide non-formulary medication at an MTF -for Rxs written by MTF providers -for Rxs written by civilian provider to whom the patient was referred by an MTF

11. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 11 Medical Necessity to Use Non-formulary Drugs Use of the formulary drug is contraindicated Patient experiences or is likely to experience significant adverse effects from formulary drugs Formulary drugs result or are likely to result in therapeutic failure Patient previously responded to non-formulary drug and changing to a formulary drug would pose unacceptable clinical risk No alternative drug on the formulary

12. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 12 Types of Medical Necessity Determinations 3.To cover a drug that is not normally covered –Examples Brand drugs with generic equivalents Tretinoin (Retin A) for patients >35 Non-contracted statin

13. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 13 Types of Medical Necessity Determinations 4.Exceptions to quantity limits Patient has valid clinical need for quantity greater than quantity limit Use is supported by clinical literature but relatively uncommon Example: use of sildenafil for primary pulmonary hypertension requires exception to 6 tablet quantity limit

14. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 14 PA/MN Process A Patient’s Experience Provider submits PA/MN request for the patient PA/MN flag set in PDTS; patient may fill Rx Patient receives denial letter explaining 1st level appeal rights Patient requests 1st level reconsideration. Different ESI group reviews PA/MN request. Patient receives denial letter explaining 2nd level appeal rights Approved Denied Approved Patient requests 2nd level reconsideration. TMA or appeals contractor reviews PA/MN request Patient receives final denial letter. Rx will reject at TRRx & TMOP Approved Denied Patient does not pursue appeal; Rx will reject at TRRx & TMOP

15. DoD Pharmacoeconomic Center www.pec.ha.osd.mil 15 Portability of PA and MNs How do the actions of MTFs affect the entire MHS? MTF fills DO auto-generate approvals for TMOP & TRRx in PDTS for: –Prior Authorizations Approval flags are medication-specific and expire 1 year from the fill date –Medical Necessity Determinations for drugs that are non- formulary on the Uniform Formulary Approval flags are medication-specific; expiration date is open-ended (at least through life of contract) MTF fills DO NOT auto-generate approval for TMOP & TRRx in PDTS for: –Medical Necessity Determinations for drugs not normally covered by TRICARE –Medical Necessity Determinations for exceptions to quantity limits