Drug Use Evaluation: Physician Administered Drugs (PADs)

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1 Drug Use Research & Management Program OHA Division of Medical Assistance Programs 500 Summer Street NE, E35; Salem, OR Phone Fax Drug Use Evaluation: Physician Administered Drugs (PADs) The goal of this drug use evaluation is to 1) Identify the cost and utilization centers of the PADs by drug class. 2) Look for opportunities to improve prescribing efficiency and/or cost effectiveness within drug classes. 3) Propose prescribing interventions with the highest return on investment. Background Nationally, traditional drug costs are growing at less than 1% annually while specialty drugs are growing at more than 17% annually. 1 The Oregon Health Plan fee-for-service traditional drug costs are actually trending down largely due to the new generic antipsychotics. The PAD trend is also flat over the last two years probably due to two successful initiatives: 1) implementation of ASP based reimbursement and 2) implementation of a sole source 340b contract for hemophilia management. In addition, PAD costs have been reduced by the capture of PAD claim NDCs for federal rebate collection. However, it is estimated there are over 30 new molecular entities in the specialty drug pipeline that will be approved by the end of Oncology is a target area, with an increase in the number of more targeted and specialized therapies. With that, there is an expectation that the PAD trend will again increase at a high rate due to the lack of generic competition and the complexity of the drug therapy. 2 Methods: All paid, clean, fee-for-service outpatient and professional claims (Types: O, C, M, B) with a procedure code beginning in Jxxxx or in group 6069 (i.e. the codes captured for rebate collection) with service dates from July 1, 2011 through June 30, 2012 were reviewed. These were linked to the drug file for classification using the most prevalent National Drug Code (NDC) captured on the claims for a single procedure code. This classification was manually reviewed and where the procedure code description was in conflict with the NDC code, the claim was reclassified to the procedure code description. Preferred Drug List (PDL) classes were used where possible. Other high cost (>$50,000/year) procedure codes were manually grouped by a pharmacist.

2 Results Over $16 million was spent on PADs during the time period. This is roughly 10% of all fee-for-service drug costs. However, the total is skewed by the mental health drug carve out. So, the PADs are likely more than 20% drug costs if only fee-for-service patients are considered. The top ten drugs by the amount paid are displayed in Table 1. PAD claims billed. They represent 56% of the total PAD costs and just 5% of the total TABLE 1 TOP TEN PHYSICIAN ADMINISTERED DRUGS BY PAID AMOUNT Unique Class Code Code Description Sum Amount Paid Pct Total Claim Count Pct Total HEMO J7192 Factor Viii Recombinant Nos $1,977, % % ONC J9355 Trastuzumab Injection $1,650, % % CSF J2505 Injection, Pegfilgrastim 6mg $1,620, % % ONC J9171 Docetaxel Injection $754, % % HEMO J7186 Antihemophilic Viii/Vwf Comp $630, % % CONTRACEPT J7302 Levonorgestrel Iu Contracept $561, % % HEMO J7185 Xyntha Inj $496, % % TIM J1745 Infliximab Injection $496, % % ONC J9310 Rituximab Injection $417, % % EPO Q4081 Epoetin Alfa, 100 Units Esrd $408, % % Author: Ketchum October 30, 2012 Page 2

3 The top ten drugs by claim count are displayed in Table 2. In contrast these represent just 4% of PAD costs but 38% of PAD claims billed. TABLE 1 TOP TEN PHYSICIAN ADMINISTERED DRUGS BY CLAIM COUNT Class Code Code Description Sum Amt Paid Pct Total Sum ClmCnt Pct Total EMET J2405 Ondansetron Hcl Injection $107, % % CONTRACEPT J1055 Medrxyprogester Acetate Inj $114, % % SAO J3010 Fentanyl Citrate Injeciton $67, % % SAO J1170 Hydromorphone Injection $76, % % DEXAMETHASONE J1100 Dexamethasone Sodium Phos $30, % % NSAID J1885 Ketorolac Tromethamine Inj $37, % % MIDAZOLAM J2250 Inj Midazolam Hydrochloride $44, % % Infusion Fluids J7030 Normal Saline Solution Infus $58, % % SAO J2270 Morphine Sulfate Injection $46, % % Infusion Fluids J7050 Normal Saline Solution Infus $88, % % Author: Ketchum October 30, 2012 Page 3

4 The top ten drug classes represent 89% of PAD costs with oncology and oncology-related drugs (CSF, EMET, and BONE) accounting for 47%. See Figure 1 below. FIGURE 1 PHYSICIAN ADMINISTER DRUG CLASS DISTRIBUTION BY AMOUNT PAID IG 2% EPO 3% BONE 2% MB 1% All others combined 11% ONC 31% EMET 4% TIM 4% CONTRACEPT 8% CSF 11% HEMO 23% Additional detail about drug distribution by class is included in the Appendix. Author: Ketchum October 30, 2012 Page 4

5 Discussion The overwhelming majority of PAD costs are associated with oncology treatment. It is an area that has been largely devoid from drug use management with the exception of the erythropoietin clinical use criteria. Siddiqui and Rajkumar postulate several reasons for this including; most cancers are incurable, patients are treated with each approved agent (sequentially or in combination), creating a virtual monopoly because the use of one drug does not automatically mean that the others are no longer needed. Third, even when the monopoly is broken with the arrival of new and improved versions of an approved drug, the older (and by now generic) drug tends to be viewed as substandard treatment, thereby perpetuating the situation. Fourth, the very nature of cancer, and the seriousness of the diagnosis, plays a role in that patients and physicians are often willing to pay the high price of treatment even for marginal improvements in outcome. Finally, our systems provide an incentive to administer more chemotherapy, and there are legal barriers that prevent agencies such as the FDA from taking economic and cost-effectiveness considerations into account when approving new drugs. 3 However, they and others have recommended value-based coverage to blunt the rising costs of these and other PADs. 4 There is opportunity to optimize the cost-effectiveness of oncology related anti-emetic use and bone metabolism drug use through implementation of the PDL on medical claims. The recent review of CSF drug use did not identify any opportunities. Erythropoetin drug use is primarily associated with end stage renal disease and will benefit from implementation of the PDL on medical claims. Hemophilia drug use was optimized with implementation of the sole source 340b contract for both drug procurement and disease management. Surprisingly, contraception is associated with 8% of total PAD costs. The apparent high use of vaginal rings and IUD needs to be evaluated for value. While these state expenditures are matched from the federal government at 95%, they warrant closer scrutiny. Other areas that need further investigation are the use of immunoglobulin and drugs for muscle blockade. Of particular note is that natalizumab, a drug with limited indications for Multiple Sclerosis and Crohn s Disease and which has a black box warning for increased risk of progressive multifocal leukoencephalopathy, ranks in the top 25 drugs by cost at $174,000 per year on 145 claims. Author: Ketchum October 30, 2012 Page 5

6 Recommendations: 1) Close any new PAD HCPC codes until reviewed by P&T for appropriateness (PDL class, OHP coverage, etc.) 2) Coordinate coverage of drugs billed via drug claims and medical claims a. Close HCPC codes for self-administered drugs and close NDCs for clinic administered drugs b. Establish a duplicate claim edit across all claims (same patient, same drug, same DOS) where it is appropriate to bill in either program. c. Phase in the current drug PA requirements for medical claims starting with classes with limited numbers of providers to target education of the PA process (i.e. BONE, EMET, EPO, MS, TIMS) d. Insure that provider reimbursed amounts are similar in both programs. 3) Work with oncology specialists to develop a management plan using best practices to possibly include the following: a. Implement PA for NCCN guidelines adherence of high cost/high risk oncology drugs b. Implement value-based reimbursement of oncology drugs i. Higher reimbursement margin to providers and no barriers for high value drugs ii. Limit coverage or limit reimbursement margin for drugs with marginal benefit at higher cost 4) Evaluate use of IU and vaginal ring contraception versus other forms. 5) Consider prior authorization of natalizumab, a drug with limited indications for Multiple Sclerosis and Chron s Disease and a black box warning for risk of progressive multifocal leukoencephalopathy. 6) Follow-up with specific DUEs of immune globulin and musclular blockade drugs. 1 The Express Scripts Research & New Sollutions Lab. Express Scripts 2011 Drug Trend Report. Research - Express-Scripts.com Available at: Accessed October 29, RxOutlook. SxC Health Solutions, Inc. 6 (5) 4 th quarter Subscription required. 3 Siddiqui M, Rajkumar SV. The High Cost of Cancer Drugs and What We Can Do About It. Mayo Clinic Proceedings. 2012;87(10): James C. Robinson. Applying Value-Based Insurance Design To High-Cost Health Services. Health Affairs, 29, no.11 (2010): Author: Ketchum October 30, 2012 Page 6

7 Appendix 1 ONCOLOGY DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J9355 Trastuzumab Injection $1,650,472 31% 736 7% J9171 Docetaxel Injection $754,596 14% 414 4% J9310 Rituximab* Injection $417,645 8% 255 2% J9035 Bevacizumab^ Injection $326,944 6% 941 9% J9263 Oxaliplatin $300,091 6% 193 2% J9041 Bortezomib Injection $196,413 4% 227 2% J9264 Paclitaxel Protein Bound $180,355 3% 121 1% J9305 Pemetrexed Injection $167,607 3% 65 1% J9201 Gemcitabine Hcl Injection $160,859 3% 424 4% J9055 Cetuximab Injection $122,559 2% 81 1% J9395 Injection, Fulvestrant $108,510 2% 115 1% J9265 Paclitaxel Injection $81,587 2% 664 6% J9070 Cyclophosphamide 100 Mg Inj $74,272 1% 564 5% J9033 Bendamustine Injection $71,319 1% 53 0% J9266 Pegaspargase Injection $70,185 1% 14 0% J9207 Ixabepilone Injection $36,636 1% 17 0% J9179 Eribulin Mesylate Injection $34,801 1% 20 0% J9045 Carboplatin Injection $29,479 1% 421 4% J9351 Topotecan Injection $27,840 1% 52 0% All others combined $222,870 4% % * ALSO USED OFF-LABEL FOR RHEUMATOID ARTHRITIS, ITP, LUPUS AND SEVERAL OTHER INDICATIONS ^ALSO USED OFF-LABEL FOR AMD, DME, BREAST CA AND SEVERAL OTHER INDICATIONS Author: Ketchum October 30, 2012 Page 7

8 HEMOPHILIA DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J7192 Factor Viii Recombinant Nos $1,977,723 55% % J7186 Antihemophilic Viii/Vwf Comp $630,238 17% 41 16% J7185 Xyntha Inj $496,659 14% 21 8% J7198 Anti-Inhibitor $314,630 9% 18 7% J7195 Factor Ix Recombinant $188,409 5% 26 10% J7189 Factor Viia $16,898 0% 1 0% CSF DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J2505 Injection, Pegfilgrastim 6mg $1,620,405 94% % J1441 Filgrastim 480 Mcg Injection $50,809 3% 77 8% J1440 Filgrastim 300 Mcg Injection $30,621 2% % J2562 Plerixafor Injection $19,198 1% 2 0% J2820 Sargramostim Injection $282 0% 1 0% Author: Ketchum October 30, 2012 Page 8

9 CONTRACEPTION DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J7302 Levonorgestrel Iu Contracept $561,305 42% % J7307 Etonogestrel Implant System $274,751 21% 749 6% J7303 Contraceptive Vaginal Ring $173,863 13% % J1055 Medrxyprogester Acetate Inj $114,786 9% % J7300 Intraut Copper Contraceptive $105,999 8% 389 3% J7304 Contraceptive Hormone Patch $88,213 7% % J1380 Estradiol Valerate 10 Mg Inj $2,183 0% 31 0% J1410 Inj Estrogen Conjugate 25 Mg $355 0% 9 0% J1051 Medroxyprogesterone Inj $239 0% 12 0% J2675 Inj Progesterone Per 50 Mg $0 0% 1 0% J1000 Depo-Estradiol Cypionate Inj $0 0% 5 0% TIMS DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J1745 Infliximab Injection $496,463 84% % J0129 Abatacept Injection $59,362 10% % J3262 Tocilizumab Injection $32,886 6% 78 10% Author: Ketchum October 30, 2012 Page 9

10 ANTIEMETIC DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J2469 Palonosetron Hcl $251,840 46% % J1453 Fosaprepitant Injection $135,502 25% 635 5% J2405 Ondansetron Hcl Injection $107,823 20% % J2550 Promethazine Hcl Injection $23,400 4% % J2765 Metoclopramide Hcl Injection $8,342 2% 672 5% Q0179 Ondansetron Hcl 8 Mg Oral $6,005 1% 236 2% J1790 Droperidol Injection $5,648 1% 405 3% J1626 Granisetron Hcl Injection $3,779 1% 447 3% S0181 Ondansetron 4 Mg $3,268 1% 108 1% J0780 Prochlorperazine Injection $1,045 0% 97 1% J8501 Oral Aprepitant $439 0% 2 0% J1260 Dolasetron Mesylate $350 0% 11 0% J8499 Oral Prescrip Drug Non Chemo $137 0% 17 0% Q0170 Promethazine Hcl 25 Mg Oral $98 0% 27 0% J8597 Antiemetic Drug Oral Nos $71 0% 1 0% J3490 Drugs Unclassified Injection $59 0% 22 0% Q0166 Granisetron Hcl 1 Mg Oral $55 0% 2 0% Q0169 Promethazine Hcl 12.5mg Oral $47 0% 11 0% J9999 Chemotherapy Drug $33 0% 5 0% S0119 Ondansetron 4 Mg $29 0% 99 1% Q0165 Prochlorperazine Maleate10mg $13 0% 5 0% Q0164 Prochlorperazine Maleate 5mg $9 0% 3 0% Q0181 Unspecified Oral Anti-Emetic $3 0% 3 0% Author: Ketchum October 30, 2012 Page 10

11 ERYTHROPOETIC DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total Q4081 Epoetin Alfa, 100 Units Esrd $408,248 75% % J0881 Darbepoetin Alfa, Non-Esrd $92,489 17% % J0885 Epoetin Alfa, Non-Esrd $31,392 6% % J0882 Darbepoetin Alfa, Esrd Use $12,009 2% 99 4% IMMUNE GLOBULIN DETAIL Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J1569 Gammagard Liquid Injection $206,154 62% 43 30% J1572 Flebogamma Injection $59,529 18% 56 39% J1459 Inj Ivig Privigen 500 Mg $52,295 16% 20 14% J1568 Octagam Injection $12,983 4% 22 15% J1561 Gamunex/Gamunex C $970 0% 1 1% BONE METABOLISM DRUGS Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J3487 Zoledronic Acid $190,302 69% % J0897 Denosumab Injection $39,321 14% 78 13% J3488 Reclast Injection $33,473 12% 84 14% J3490 Drugs Unclassified Injection $6,487 2% 12 2% J2430 Pamidronate Disodium /30 Mg $4,149 2% 99 16% J1740 Ibandronate Sodium Injection $799 0% 12 2% Author: Ketchum October 30, 2012 Page 11

12 MUSCLE BLOCKADE DRUGS Code Code Description Sum Amount Paid Pct Total Unique Claim Count Pct Total J0475 Baclofen 10 Mg Injection $111,156 51% % J0585 Injection,Onabotulinumtoxina $94,957 44% % J0330 Succinycholine Chloride Inj $3,692 2% % J0586 Abobotulinumtoxina $3,312 2% 29 4% J0588 Incobotulinumtoxin A $2,019 1% 15 2% J3490 Drugs Unclassified Injection $501 0% 8 1% J0476 Baclofen Intrathecal Trial $497 0% 11 2% J0587 Inj, Rimabotulinumtoxinb $0 0% 6 1% Author: Ketchum October 30, 2012 Page 12