20140310 Reasanz (serelaxin) ICD-10 CM Presentation Text File

Slide 1
REASANZ™ (serelaxin): request for ICD-10 PCS code for serelaxin administration

Slide 2
AGENDA
* Request for unique procedure code for serelaxin IV administration 
* Addressing unmet needs in Acute Heart Failure, through serelaxin

Slide 3
SERELAXIN – A SIGNIFICANT CLINICAL IMPROVEMENT FOR TREATMENT OF ACUTE HEART FAILURE
* Significant unmet needs exist in heart failure – growing condition with high, unchanged mortality rate over a decade
* Serelaxin – 48 hour IV infusion to improve the symptoms of acute heart failure through reduction of rate of worsening of heart failure
* Anticipated FDA approval decision – Q2 2014 
* ‘Breakthrough Therapy’ designation by FDA for serelaxin’s ongoing clinical development program 
* Applied for new technology add-on payment (NTAP) designation to CMS for FY2015
* The above supports the need for distinct identification of serelaxin administration, by a unique ICD-10 PCS code – key for NTAP process

Slide 4
CURRENT ICD-10-PCS CODES DO NOT ENABLE DISTINCT IDENTIFICATION OF SERELAXIN ADMINISTRATION
* Section: 3 Administration
* Body System: E Physiological Systems and Anatomical Regions
* Operation: 0  Introduction: Putting in or on a therapeutic, diagnostic, nutritional, physiological, or prophylactic substance except blood or blood products  
* Body System/Region
-3  Peripheral Vein
* Approach
-3 Percutaneous
* Substance
   - V Hormone
* Qualifier
   - G Insulin 
   - H Human B-type Natriuretic Peptide 
   - J Other Hormone
* Including serelaxin administration within ‘3E030VJ’ ICD-10 PCS  would not allow CMS to accurately identify serelaxin claims for NTAP, and compromise data integrity for heart failure outcomes assessment

Slide 5
INCLUDING SERELAXIN ADMINISTRATION IN ‘3E030VJ’ WILL LIKELY CAUSE CONFUSION FOR CMS – VARYING INDICATIONS, ADMINISTRATION, AND PATIENT POPULATIONS
* Serelaxin
   - Indication: Acute heart failure
   - Drug Administration: IV infusion for 48 hours, consisting of two consecutive infusions of 24 hours
   - Patient Population: Hospitalized patients with heart failure
* Examples of other drugs included in ‘3E030VJ’ ICD-10 procedure code
   - Desmopressin (DDAVP) Injection
* Indication: Diabetes Insipidus (DI); Hemophilia A; and von Willebrand's Disease
* Drug Administration: Varies by indication; IV or Subcutaneous
* Patient Population: Individuals with DI or certain bleeding disorders
   - Oxytocin (Pitocin
* Indication: Various antepartum and postpartum women’s health disorders
* Drug Administration: IV infusion (drip method) with dosage determined by the uterine response
* Patient Population: Women of child-bearing age

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WE REQUEST DISTINCT ICD-10 PROCEDURE CODE ‘3E030VR’ FOR SERELAXIN ADMINISTRATION
* Section: 3 Administration
* Body System: E Physiological Systems and Anatomical Regions
* Operation: 0  Introduction: Putting in or on a therapeutic, diagnostic, nutritional, physiological, or prophylactic substance except blood or blood products  
* Body System/Region
   - 3  Peripheral Vein
* Approach
   - 3 Percutaneous
* Substance
   - V Hormone
* Qualifier
   - G Insulin 
   - H Human B-type Natriuretic Peptide 
   - J Other Hormone
   - R Human Relaxin-2 Peptide
* A unique ICD-10-PCS code will facilitate NTAP recognition and enable CMS to appropriately track claims and generate outcomes data for heart failure

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UNIQUE DRUG ADMINISTRATION CODES HAVE BEEN GRANTED IN THE PAST, INCLUDING FOR NESIRITIDE IN HEART FAILURE
* Reasanz (serelaxin)
   - ICD-10-PCS Code: Code Requested: 3E030VR (Introduction of Human Relaxin-2 Peptide into Peripheral Vein, Open Approach)
   - Indication: Serelaxin is indicated to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure (pending final FDA review)
   - Drug Administration: IV infusion for 48 hours, consisting of two consecutive infusions of 24 hours
   - Mechanism of Action: Receptor mediated vasodilatation via the RXFP 1/2 receptors  and stimulation of nitric oxide production via the endothelin-1 B receptor
* Natrecor (nesiritide)
   - ICD-10-PCS Code: 3E030VH (Introduction of Human B-type Natriuretic Peptide into Peripheral Vein, Open Approach)
   - Indication: Natrecor is indicated to reduce pulmonary capillary wedge pressure and improved dyspnea
   - Drug Administration: IV bolus for up to 96 hours
   - Mechanism of Action: Direct vasodilation via stimulation of guanylate cyclase receptors on vascular smooth muscle and endothelial cells
* Need for a distinct ICD-10-CM procedure code for serelaxin administration - differences in indication, administration, and mechanism of action compared to nesiritide administration (3E030VH not applicable for serelaxin)

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A DISTINCT ICD-10 PCS CODE WOULD FACILITATE NTAP CLAIMS TRACKING AND ALIGN BETTER WITH UNIQUE NATURE OF SERELAXIN
* A unique ICD-10-PCS code would facilitate NTAP recognition and allow for appropriate claims tracking to generate data 
* Serelaxin does not appropriately fit with the other drugs described by CMS recommended code of 3E030VJ, and also under 3E030VH 
* Unique drug administration codes have been granted in the past, including for nesiritide in heart failure
* Since existing codes 3E030VJ and 3E030VH do not adequately and distinctly describe the administration of serelaxin, we request a new ICD-10-PCS code in association with New Technology Add-on Payment (NTAP) process

Slide 9
AGENDA
* Request for unique procedure code for serelaxin IV administration 
* Addressing unmet needs in Acute Heart Failure, through serelaxin

Slide 10
HEART FAILURE – A SERIOUS CONDITION
* ‘Heart Failure’ means that the heart isn't pumping as well as it should be
* A condition that continues and worsens, and ...COMPROMISES QUALITY OF LIFE, BY MAKING EVERYDAY ACTIVITIES, SUCH AS WALKING, STAIR-CLIMBING, AND LIFTING GROCERIES AN ORDEAL

Slide 11
HEART FAILURE IS A GROWING AND COSTLY CONDITION WITH A HIGH MORTALITY RATE
* ... affects 5.1 million Americans
   - Likely to increase to 8 million by 2030
* ... puts more elderly people in hospital than any other cause
   - Top 3 in-patient cost billed to Medicare
* ... COSTS $24.7 BILLION in direct medical costs
   - Projected to grow to $77.7 billion by 2030
* ... has high mortality rate comparable to breast, prostate and colorectal cancers
* ... CAUSES 1 in 3 patients TO die within a year of hospitalization
   - Mortality rate has barely budged over a decade

Slide 12
CURRENT AHF TREATMENT OPTIONS LARGELY UNCHANGED FROM THE 1970S
* Diuretics
   - Relieves symptoms?
* Yes
   - Reduces in-hospital WHF?
* No
   - Prolongs survival
* No
* Vasodilators
   - Relieves symptoms?
* Yes
   - Reduces in-hospital WHF?
* No
   - Prolongs survival
* No
* No
* Inotropes
   - Relieves symptoms?
* Yes
- Reduces in-hospital WHF?
* No
   - Prolongs survival
* No

Slide 13
PHASE III CLINICAL TRIAL DATA DEMONSTRATES SERELAXIN SIGNIFICANTLY IMPROVES TREATMENT OF AHF
* 19.4% improvement in dyspnea (shortness of breath)
   - Rapid relief of patient discomfort due to shortness of breath and congestion
* 47% reduction in rate of worsening of heart failure
   - Reduces in-hospital worsening of heart failure
* Reduction of biomarkers indicative of organ damage
   - May protect heart and kidney tissue
* 0.9 day reduction in hospital length of stay
   - Could potentially lower the cost burden of heart failure
* 37% reduction in CV and all-cause mortality at day 180
   - May help reduce heart failure mortality
* Similar adverse events as placebo treatment group
   - Safe acute heart failure treatment option

Slide 14
BACKUP SLIDES

Slide 15
REASANZ (SERELAXIN) OVERVIEW
* Indication: Serelaxin is a recombinant form of relaxin-2 hormone indicated to improve the symptoms of acute heart failure through reduction of the rate of worsening of heart failure
* Administration: Intravenous infusion via a peripheral vein over a 48-hour period in the inpatient hospital setting.
* Dosing: Dosage is based on body weight.  Two consecutive infusions each of 24 hours duration should be administered at a constant infusion rate of 10 mL/hour
* Packaging: Supplied as a sterile, preservative-free solution for infusion (1 mg/mL). One vial of 3.5 mL contains 3.5 mg of serelaxin

Slide 16
DIAGNOSIS CODES EXIST TO DESCRIBE SERELAXIN TARGET PATIENTS
* AHF can be defined as cases with any of seven HF ICD-9 diagnosis codes
   - ICD-9  Diagnosis: 428.10
* Description: Left heart failure
   - ICD-9  Diagnosis: 428.21
* Description: Acute systolic heart failure
   - ICD-9  Diagnosis: 428.23
* Description: Acute on chronic systolic heart failure
   - ICD-9  Diagnosis: 428.31
* Description: Acute diastolic heart failure
   - ICD-9  Diagnosis: 428.33
* Description: Acute on chronic diastolic heart failure
   - ICD-9  Diagnosis: 428.41
* Description: Acute combined systolic and diastolic heart failure
   - ICD-9  Diagnosis: 428.43
* Description: Acute on chronic combined systolic and diastolic heart failure
* Certain comorbidities are prevalent among the AHF population
   - Most Prevalent
* Renal Insufficiency 
* Diabetes Mellitus 
* Ischemic Heart Disease 
* Hyperlipidemia 
* Atrial Fibrillation/Flutter
   - Least Prevalent
* Cardiac valvular Disease 
* Chronic Lung Disease 
* Stroke
* Anemia
