ACQUIRED RARE DISEASE DRUG THERAPY EXCEPTION PROCESS

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1 ADMINISTRATIVE POLICY ACQUIRED RARE DISEASE DRUG THERAPY EXCEPTION PROCESS Plicy Number: ADMINISTRATIVE 19.8 T Effective Date: Octber 1, 014 Table f Cntents CONDITIONS OF COVERAGE... BENEFIT CONSIDERATIONS... DESCRIPTION OF SERVICE.. DEFINITIONS... POLICY AND RATIONALE... TREATMENT/APPLICATION GUIDELINES... PAYMENT GUIDELINES... REFERENCES... POLICY HISTORY/REVISION INFORMATION... Plicy Histry Revisin Infrmatin The services described in Oxfrd plicies are subject t the terms, cnditins and limitatins f the Member's cntract r certificate. Unless therwise stated, Oxfrd plicies d nt apply t Medicare Advantage enrllees. Oxfrd reserves the right, in its sle discretin, t mdify plicies as necessary withut prir written ntice unless therwise required by Oxfrd's administrative prcedures r applicable state law. The term Oxfrd includes Oxfrd Health Plans, LLC and all f its subsidiaries as apprpriate fr these plicies. Certain plicies may nt be applicable t Self-Funded Members and certain insured prducts. Refer t the Member's plan f benefits r Certificate f Cverage t determine whether cverage is prvided r if there are any exclusins r benefit limitatins applicable t any f these plicies. If there is a difference between any plicy and the Member s plan f benefits r Certificate f Cverage, the plan f benefits r Certificate f Cverage will gvern. CONDITIONS OF COVERAGE Page Related Plicies: Experimental/ Investigatinal Treatment Clinical Trials Applicable Lines f Business/Prducts Benefit Type Referral Required (Des nt apply t nn-gatekeeper prducts) Authrizatin Required (Precertificatin always required fr inpatient admissin) Precertificatin with Medical Directr Review Required Applicable Site(s) f Service (If site f service is nt listed, Medical Directr review is required) Special Cnsideratins This plicy applies t Oxfrd New Yrk Cmmercial plan membership General benefits package N Yes 1 Yes 1 Inpatient, Outpatient, Office 1 Precertificatin with review by a Medical Directr review r their designee is required. This plicy may need t be reviewed in cnjunctin with Oxfrd's plicy n Experimental/Investigatinal Treatment. Acquired Rare Disease Drug Therapy Exceptin Prcess: Administrative Plicy (Effective 10/01/014) , Oxfrd Health Plans, LLC 1

2 BENEFIT CONSIDERATIONS Essential Health Benefits fr Individual and Small Grup: Fr plan years beginning n r after January 1, 014, the Affrdable Care Act f 010 (ACA) requires fully insured nn-grandfathered individual and small grup plans (inside and utside f Exchanges) t prvide cverage fr ten categries f Essential Health Benefits ( EHBs ). Large grup plans (bth self-funded and fully insured), and small grup ASO plans, are nt subject t the requirement t ffer cverage fr EHBs. Hwever, if such plans chse t prvide cverage fr benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dllar limits n thse benefits t be remved n all Grandfathered and Nn-Grandfathered plans. The determinatin f which benefits cnstitute EHBs is made n a state by state basis. As such, when using this guideline, it is imprtant t refer t the enrllee s specific plan dcument t determine benefit cverage. DESCRIPTION OF SERVICE/BACKGROUND INFORMATION Cverage fr experimental and investigatinal treatments and prcedures is specifically excluded under the Member's Certificate with Oxfrd. In additin t the clinical situatins fr which Oxfrd will apprve benefits fr Experimental and Investigatinal Therapy (see Experimental/Investigatinal Treatment plicy) and Clinical Trials (see Clinical Trials fr Cmmercial Plans plicy) Oxfrd will als cnsider requests fr ff-label usage f an FDA apprved drug where the Member has an acquired rare disease and the drug therapy request is clinically reasnable. Off-label drug therapies are thse medical therapies that use a FDA apprved drug fr a nnindicated use. DEFINITIONS Acquired rare disease: The disease is develped after birth and ccurs infrequently and in a small number f patients. The disease will be cnsidered rare if there are nt enugh patients with the disease t have a standard f care r justify a clinical trial r prvide enugh data t have a peer review published study at the time f the request. Center f Excellence: Academic medical centers that rutinely cnduct natinally spnsred, multi-centered clinical trials in the categry f disease the Member has, and have received designatin as an institutin with special standing in the treatment f the disease (fr example, a Cmprehensive Cancer Center fr the treatment f cancer POLICY AND RATIONALE Oxfrd recgnizes that fr certain types f rare diseases there may be n standard f care treatment r peer reviewed dcuments in scientific and medical literature which establish that an experimental and/r investigatinal treatment r prcedure may be mre beneficial than the standard treatments available t treat a Member's acquired rare disease. Oxfrd has determined that it will create a limited exceptin t the exclusin f experimental and investigatinal treatments and apprve benefits fr in-netwrk drug therapies that meet the criteria set frth in this plicy. Such cverage is subject t the Member's ther benefits and exclusins. Oxfrd's determinatin f whether the criteria have been met will be based upn the pinin f an independent specialist/cnsultant/ peer reviewer with expertise in the area f practice apprpriate t treat the Member's acquired rare disease. Unprven Therapies: Under n circumstances will this plicy extend cverage t unprven therapies. Unprven therapies are treatments r prcedures that lack significant medical dcumentatin and/r evidence t supprt their medical effectiveness. Oxfrd des nt prvide cverage fr any treatment mdality that has nt been prven medically effective (ther than as Acquired Rare Disease Drug Therapy Exceptin Prcess: Administrative Plicy (Effective 10/01/014) , Oxfrd Health Plans, LLC

3 discussed belw) r is nt generally recgnized as effective r apprpriate fr the particular diagnsis r treatment f the Member's particular cnditin r disease. TREATMENT/APPLICATION GUIDELINES After receiving a request fr experimental treatment f an acquired rare disease, an Oxfrd Medical Directr will review the relevant clinical and patient infrmatin. As part f that review, the Medical Directr, in his/her discretin, will determine whether the disease is an acquired rare disease and whether the prpsed drug therapy is clinically reasnable. Fr purpses f this plicy, clinically reasnable means: The drug is FDA apprved and is nt cntraindicated fr the prpsed use. There is evidence f early success with the drug therapy and at least a small number f patients with the same acquired rare disease have respnded t treatment but there is nt enugh infrmatin t have a peer review published study at this time. The evidence shwing early success is frm a Center f Excellence which treats Members with the same acquired rare disease. The benefit likely exceeds the risk t the Member in receiving the drug therapy. The treatment results will be available fr use by the medical cmmunity by establishment f a patient registry t evaluate the effectiveness f the drug therapy fr patients with this acquired rare disease. The Member has nt failed a previus curse r trial f the drug therapy. The Member des nt have any ther cmrbidity which wuld preclude the prpsed drug therapy. The Member has signed an infrmed cnsent. The Medical Directr will cnsult with the specialist wh has received early success with use f the prpsed treatment if pssible and/r an utside cnsultant. The specialist/cnsultant must have credentials in the specific discipline f medicine that treats the Member's acquired rare disease. That specialist r cnsultant will be asked t certify that the basis f the medical dcuments submitted that: The Member has an acquired rare disease; That there have nt been, and are nt likely t be in the perid f time during which the Member must be treated, either clinical trials r articles published in the peer reviewed medical literature shwing that the prpsed treatment is likely t benefit patients wh have the specific rare disease The requested drug therapy prtcl is clinically reasnable t treat the Member's acquired rare disease, with stated ratinales that supprt that cnclusin That, based n the cnsultant's pinin, the benefits f the treatment are likely t utweigh the risks f treatment. The specialist/cnsultant has treated patients with this cnditin. Precertificatin will be required fr each curse f drug therapy. If the Member des nt respnd t the initial prescribed curse f drug therapy, Oxfrd will nt cntinue t apprve the therapy and the therapy will be denied as an unprven therapy. Dcumentatin: The fllwing dcumentatin must be submitted t Oxfrd demnstrating that the criteria belw have been satisfied. Withut all such dcumentatin, Oxfrd will deny any such request. Acquired Rare Disease Drug Therapy Exceptin Prcess: Administrative Plicy (Effective 10/01/014) , Oxfrd Health Plans, LLC 3

4 Necessary Infrmatin: The fllwing supprting dcumentatin must be prvided by the Member and/r the Member's prvider fr cnsideratin f the drug therapy: Certificatin frm the Member's attending physician which includes: A statement that the Member has an acquired rare disease; and A statement f the evidence relied upn t recmmend the prpsed drug therapy and a statement f why any standard therapy available wuld nt be beneficial, wuld be ineffective r wuld be inapprpriate, including an assessment f the risks and benefits f the prpsed treatment; and A cpy f any available medical and scientific evidence, upn which the attending physician based his recmmendatin fr the prpsed treatment. *The attending physician must be a bard certified r bard eligible physician qualified t practice in the area f practice apprpriate t treat the Member's cnditin. A written descriptin f the prpsed treatment (r prtcl if available), which must include: Specific gals; A ratinale and backgrund fr the plan; Criteria fr patient selectin; Specific directins fr administering the therapy; Specific directins fr the mnitring f patients; A definitin f quantitative measures fr determining treatment r interventin respnse; and Methds fr dcumenting and treating adverse reactins t the treatment r interventin. A cpy f the Member's infrmed cnsent frm; A cpy f the Member's medical and treatment recrds, including results f tests r studies, shwing the Member's current cnditin and any treatment the Member has received fr the cnditin; The available clinical r pre-clinical data that indicate the effectiveness f the prpsed drug therapy fr treatment f the Member's cnditin and the cntact infrmatin fr the specialist wh can discuss the evidence f early success f the drug therapy with an Oxfrd Medical Directr. Depending upn the nature f the prpsed drug therapy and/r the Member's disease, the specialist/ cnsultant r Oxfrd may require additinal dcumentatin t review the requested therapy. Oxfrd will als accept and cnsider any additinal pertinent clinical dcumentatin, peer review publicatins and/r relevant data cncerning the prtcl that the Member and/r the Member's physician wuld like t prvide in supprt f the request fr the drug therapy PAYMENT GUIDELINES This plicy creates a limited exceptin t the ttal exclusin f benefits fr Experimental/ Investigatinal treatments. Generally, payment f benefits under this plicy is limited t participating prviders within Oxfrd's netwrk cntracted specifically t prvide these services. Oxfrd will nly cnsider requests fr acquired rare disease treatment at an ut-f-netwrk Center f Excellence if the requested drug therapy meets the criteria in this plicy and n netwrk physician will treat the Member using the requested drug prtcl. Even if Oxfrd apprves drug Acquired Rare Disease Drug Therapy Exceptin Prcess: Administrative Plicy (Effective 10/01/014) , Oxfrd Health Plans, LLC 4

5 therapy at an ut-f-netwrk Center f Excellence, Oxfrd reserves the right t mve the Member t an in-netwrk prvider fr future treatments if an Oxfrd prvider becmes available. In-netwrk and ut-f-netwrk benefits are subject t all applicable cst sharing requirements. Out-f-netwrk services will be paid based upn the ut-f-netwrk r UCR fee schedule applicable t the Member's plan and subject t the Member's ut-f-netwrk cst-share. REFERENCES 1. NY Insurance Law 4900, 4910, 4914; NY Scial Services Law 08. POLICY HISTORY/REVISION INFORMATION Date 04/17/01 10/01/014 Actin/Descriptin Changed plicy type classificatin frm Clinical t Administrative (n change in cntent/guidelines) Rerganized plicy cntent Added benefit cnsideratins language fr Essential Health Benefits fr Individual and Small Grup plans t indicate: Fr plan years beginning n r after January 1, 014, the Affrdable Care Act f 010 (ACA) requires fully insured nngrandfathered individual and small grup plans (inside and utside f Exchanges) t prvide cverage fr ten categries f Essential Health Benefits ( EHBs ) Large grup plans (bth self-funded and fully insured), and small grup ASO plans, are nt subject t the requirement t ffer cverage fr EHBs; hwever, if such plans chse t prvide cverage fr benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dllar limits n thse benefits t be remved n all Grandfathered and Nn- Grandfathered plans The determinatin f which benefits cnstitute EHBs is made n a state by state basis; as such, when using this guideline, it is imprtant t refer t the enrllee s specific plan dcument t determine benefit cverage Archived previus plicy versin ADMINISTRATIVE 19.7 T Acquired Rare Disease Drug Therapy Exceptin Prcess: Administrative Plicy (Effective 10/01/014) , Oxfrd Health Plans, LLC

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