{
 "query": "sacubitril / valsartan",
 "ingredient": "sacubitril / valsartan",
 "slug": "sacubitril-valsartan",
 "rxcui": "1656339",
 "brands": [
  "Entresto"
 ],
 "names": [
  "sacubitril / valsartan"
 ],
 "components": [
  {
   "ingredient": "sacubitril",
   "slug": "sacubitril",
   "grade": "C",
   "total": 74,
   "scores": {
    "safety": "C",
    "evidence": "C",
    "regulatory": "A",
    "conflict": "A",
    "options": "C"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "",
   "first_approval": ""
  },
  {
   "ingredient": "valsartan",
   "slug": "valsartan",
   "grade": "C",
   "total": 73,
   "scores": {
    "safety": "C",
    "evidence": "C",
    "regulatory": "A",
    "conflict": "D",
    "options": "A"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "12/23/1996",
   "first_approval": "19961223"
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "19961223",
  "first_approval_fmt": "",
  "anda": 0,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 1132925.46,
  "records": 58085,
  "by_name": [
   [
    "Entresto",
    1132925.46
   ]
  ],
  "names_checked": [
   "sacubitril / valsartan",
   "Entresto"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3898977,
  "beneficiaries": 795388,
  "spend": 4020466403.9,
  "by_brand": [
   {
    "brand": "Entresto",
    "claims": 3898804,
    "per_claim": 1031.1679393,
    "is_generic": false
   },
   {
    "brand": "Entresto Sprinkle",
    "claims": 173,
    "per_claim": 836.51734104,
    "is_generic": false
   }
  ],
  "per_claim": 1031.1593025298687
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, sacubitril (70)",
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death share in reports is near or below the FAERS average (1.0x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, valsartan (63)",
    "615 randomized trials and 100 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 31% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, valsartan (93)",
    "Recalls since 2016: 0 Class I, 17 Class II, 3 Class III across 24 generic makers (-7)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Graded by its riskiest ingredient, valsartan (60)",
    "Pharma paid doctors $74 tied to this drug last year: negligible",
    "Named in 1 active federal multidistrict litigation(s) (-40)",
    "For the combination product itself:",
    "Pharma paid doctors $1,132,925 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, sacubitril (70)",
    "Sold over the counter under an FDA monograph: no application to approve, many makers",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "This is a fixed combination of sacubitril and valsartan. Why both together, instead of only the one I need?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are cardiac failure, hypotension, acute kidney injury, oedema peripheral. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)",
  "The most-reported problems in FDA's adverse event data are fatigue, dyspnoea, diarrhoea. How would we recognize and handle those?",
  "Why this one over azilsartan medoxomil, candesartan, eprosartan? What would make you pick one of those instead?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?"
 ]
}